420 Pharmaceutical jobs in Singapore
Clinical Research Associate II (CRA2)
Posted 1 day ago
Job Viewed
Job Description
Overview
Join to apply for the Clinical Research Associate II (CRA2) role at Fortrea
1 week ago Be among the first 25 applicants
Join to apply for the Clinical Research Associate II (CRA2) role at Fortrea
Responsibilities- Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- Responsible for all aspects of site management as prescribed in the project plans.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Fluent in local office language and in English, both written and verbal.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- External Candidates: University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND a minimum of 2 years of Clinical Monitoring experience.
- Internal Candidates: Internal candidates with a minimum of 2 years of Clinical Monitoring experience.
- Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
- Ability to work with minimal supervision.
- Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Good planning, organization, and problem-solving abilities.
- Works efficiently and effectively in a matrix environment.
- Travel Requirement is 60% of the time (traveling to study sites).
Learn more about our EEO & Accommodations request here.
#J-18808-LjbffrAssociate Clinical Research Coordinator / Clinical Research Coordinator
Posted 1 day ago
Job Viewed
Job Description
Press Tab to Move to Skip to Content Link
Select how often (in days) to receive an alert:
Associate Clinical Research Coordinator / Clinical Research CoordinatorJob Category: Research
Posting Date: 27 Mar 2025
Job Description:
You will provide research support service for clinical research, in accordance to the applicable regulatory, Good Clinical Practice and protocol requirements. You will work closely with the Principal Investigators (PIs), to assist them with organisation of study initiation meetings, IRB submission, protocol development, preparation of study logistics, recruitment, data collection and management, study documentation, study monitoring and other duties as assigned.
You will support and participate in the SGH mission of providing quality patient care, education, and research.
Job Requirements:
- Bachelor Degree in Nursing/Science or Diploma in Clinical Trials Management
- Fresh graduate or with at least one year of relevant experience
- Proficient in using MS Office software
- Effectively bilingual
- Excellent oral and written communication skills
Senior Lead Clinical Research Associate, Research Compliance Management
Posted 1 day ago
Job Viewed
Job Description
Press Tab to Move to Skip to Content Link
Select how often (in days) to receive an alert:
Senior Lead Clinical Research Associate, Research Compliance ManagementJob Category: Allied Health Professional
Posting Date: 9 May 2025
We are seeking a Senior Lead Clinical Research Associate to oversee clinical research compliance management across SingHealth institutions. In this role, you will ensure adherence to regulatory requirements including the Human Biomedical Research Act, Health Products Act, International Council for Harmonisation - Good Clinical Practice guidelines and relevant Standard Operating Procedures.
Your responsibilities will include planning and conducting monitoring visits, preparing comprehensive post-visit reports, recommending preventive and corrective measures for compliance, and ensuring resolution of findings. You will also provide administrative support to departmental operations, develop education programes, train new Clinical Research Associates, provide supervisory monitoring and chair department meetings.
Requirements:
At least 10 years of relevant experience in clinical trials, including clinical trials monitoring with 4 years in a supervisory or management role
Strong interpersonal, leadership and communication skills (both verbal and written)
Demonstrated analytical, problem-solving and organisational skills
Ability to work independently and collaboratively, with proven capability to prioritise tasks and manage competing deadlines
Proficiency with Microsoft Office applications
#J-18808-LjbffrE&I Engineer (Petrochemical / Pharmaceutical)
Posted 1 day ago
Job Viewed
Job Description
Benefits Summary:
- Up $6500 + Variable Bonus + Benefits
- 5 Days work week
- Working Location: West
- Transport provided
- MNC with good working environment
Responsibilities:
- Oversee a team of seniors & superintendents for the operations of plants
- Propose ideas and plans for management consideration for improvement on initiatives and projects
- Prepare and plan for daily maintenance activities to executive safely and efficiently within schedule & budget
- Execute assigned engineering and minor modification works, focusing on electrical &instrumentation aspects, in assigned plants.
- Any ad-hoc duties as required
Interested candidates, please submit your updated resume in MS format by using the Apply Now Button.
Alternatively, you may also email your resume to us at .
Follow us on Facebook for more info:
Text us on WhatsApp for more details:
Follow us on Telegram for more job opportunities:
Our dedicated and approachable E&C consultants will get back to you soon for a confidential discussion.
By submitting your application or resume to us, you will be deemed to have agreed and consented us that we may collect, use or disclose your personal information for purpose in connection with the services provided by us.
**We regret to inform that only shortlisted candidates would be notified. **
Edward TOH
Registration No: R
EA License No: 20C0278
Quality System Regulatory Affairs Specialist APJ
Posted 1 day ago
Job Viewed
Job Description
Overview
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Microsystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Shape the Future with Us!
At Leica Microsystems, we have been shaping the future for over 175 years with groundbreaking optical and digital solutions. With a culture rooted in customer focus, innovation, and teamwork, we lead the market in microscopy, imaging, and analysis, unveiling the invisible and empowering our customers to build a better, healthier world.
Joining Leica Microsystems means contributing to scientific discoveries and supporting surgeons in making critical decisions. Our advanced microscopes and AI-based image analysis solutions enable users to gain profound insights into development and engineering challenges. Here, you will work on meaningful projects alongside passionate colleagues, driving progress and pushing the boundaries of what’s possible.
Learn about the Danaher Business System which makes everything possible.
Role and ResponsibilitiesThe Quality System Regulatory Affairs Specialist APJ is responsible for maintaining the existing Quality Management System (QMS) according to standards (ISO13485, ISO9001, ISO14001) and applicable regulatory requirements for Leica Microsystems Commercial Offices in APJ region.
This position reports to the Manager RA/QA Commercial Operations & EHS and is part of the Global Quality Systems located in Singapore and will be an on-site role.
In this role, you will have the opportunity to:
- Supports the APJ functional commercial (CO) teams to maintain compliance with the QMS processes further interacting directly with 3rd party auditors during site assessments, providing overall leadership to the functional levels and support for all regulatory and quality assurance (RA/QA) related issues at CO side.
- Make recommendations for the continuous improvement of QMS processes and directs resources in support of Key Performance Indicators (KPI) and other metrics. Responsible to verify effectiveness of QMS by internal audits.
- Manage the QMS platform for creation of quality documents and quality trainings
- Responsible for product registration activities in APJ region where required. Maintain a positive relationship with relevant government and regulatory authorities. Support the APJ regulatory team in their registration activities
- Responsible to coordinate post market surveillance (PMS) activities like adverse event/complaint, recall/field corrective actions in cooperation with the respective Business Units. Validation of processes impacting on the QMS as needed.
The essential requirements of the job include
- Minimum 2-3 years proven QMS and/or RA experience in the Regulated Industry
- International experience in problem solving, complaint handling or equivalent
- BSc degree or equivalent in science, engineering or equivalent
- 25%
It would be a plus if you also possess previous experience in:
- Knowledge of Australian medical device regulatory requirements (preferred)
- Knowledge of APJ region regulatory requirements (preferred)
Leica Microsystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit
#J-18808-LjbffrRegulatory Affairs Specialist
Posted 1 day ago
Job Viewed
Job Description
- You will play a crucial role in supporting the product lifecycle through obsolescence. This involves assessing changes made to the device post-launch to determine the regulatory impact of these changes on the current clearance. Your responsibilities will also include ensuring regulatory compliance by conducting thorough assessments and submitting necessary documentation for product clearances and approvals from regulatory bodies such as the FDA, Notified Bodies, and others. Additionally, you will contribute to the development and updating of regulatory strategy for new product development both domestically and internationally.In this role, you will be regarded as a valuable resource within the regulatory team. While working with minimum supervision, you will have some independence in making decisions. You will collaborate with senior and supervisory staff as needed and keep your supervisor informed of the status of your work. Your tasks will involve developing and applying basic knowledge of regulatory frameworks, requirements, legislation, processes, and procedures.Your responsibilities will also include project management, writing, coordinating, and executing regulatory tasks. You will handle technical and scientific regulatory assignments of a broad nature. You will assist in the development and review of Standard Operating Procedures (SOPs) and regulatory strategies based on changes in regulations. Furthermore, you will provide regulatory input for new product development and product lifecycle planning. You will evaluate the regulatory impact of proposed changes to launched products and investigate regulatory history in relevant contexts.To be successful in this role, you are required to have a Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline. A minimum of 3 to 5 years of experience in a similar position within an R&D environment is preferred. Experience in post-market activities and change management will be advantageous. Possessing a Regulatory Affairs Certification (RAC) is also preferred.This position offers you the opportunity to contribute to regulatory compliance and strategy in a dynamic environment. Your role will involve critical decision-making, collaboration with stakeholders, and ensuring adherence to regulatory requirements throughout the product lifecycle.,
Sign-in & see how your skills match this job
Sign-in & Get noticed by top recruiters and get hired fast
Regulatory Affairs Specialist
M/S AASTHA LIFECARE CORPORATION PRIVATE LIMITED5 to 10 Yrs
Kamrup
Kamrup +9
- system
- documentation
- +12
Research Fellow / Engineer (Pharmaceutical Innovation Programme Singapore (PIPS) - AZN4
Posted 1 day ago
Job Viewed
Job Description
Organisation/Company SINGAPORE INSTITUTE OF TECHNOLOGY (SIT) Research Field Engineering Chemistry Engineering Researcher Profile First Stage Researcher (R1) Country Singapore Application Deadline 31 Dec 2025 - 00:00 (UTC) Type of Contract Other Job Status Full-time Is the job funded through the EU Research Framework Programme? Not funded by a EU programme Is the Job related to staff position within a Research Infrastructure? No
Offer DescriptionAs a University of Applied Learning, SIT works closely with industry in our research pursuits. Our research staff will have the opportunity to be equipped with applied research skill sets that are relevant to industry demands while working on research projects in SIT.
The primary responsibility of this role is to deliver on a Pharmaceutical Innovation Programme Singapore research project where you will be part of a collaborative team exploring innovative ways of understanding extrusion processing for pharmaceutical drug materials and products using rheological measurements.
Key Responsibilities
In this role, you will characterize mixtures of pharmaceutical excipients and drug materials to develop methodologies for screening hot-melt extrusion formulations and selecting optimal operating conditions using rheology, with the objective of producing amorphous-solid-dispersions. You will validate the developed processing space and operating conditions for extruded pharmaceutical formulations using a lab-scale extruder. In collaboration with researchers at the Singapore-MIT Alliance for Research and Technology (SMART), you will characterize the physical properties and performance of intermediate pharmaceutical drug products. The created methods will be transferred to the industrial partner to enhance their product development process using rheological characterization.
More specific responsibilities include:
- Participate in and manage the research project with Principal Investigator (PI), and the research team members to ensure all project deliverables are met.
- Undertake characterization of pharmaceutical active ingredients, polymeric excipients, and plasticizers for producing amorphous-solid-dispersions.
- Perform lab-scale hot-melt extrusion of pharmaceutical materials to validate predicted processing conditions and product outcomes.
- Collaborate with broader pharmaceutical research team at SMART.
- Design, execute, and interpret experiments independently.
- Author papers in high-quality journals in areas that are related to the research.
- Prepare and deliver reports and presentations for industrial partners
- Carry out Risk Assessment, and ensure compliance with Work, Safety and Health Regulations.
- Coordinate procurement and liaise with vendors/suppliers.
- Work independently, as well as within a team.
Job Requirements
- Have deep hands-on experience with at least one of the areas of polymer rheology, extrusion processing, pharmaceutical engineering with small molecules.
- Relevant competence in the areas of wet lab work, analytical instrumentation, material science and formulation
- Have an advanced degree in chemical engineering, mechanical engineering, materials science and engineering, or a related field.
- Knowledge of any of the following will be advantageous: rheology, physical characterisation, crystallisation, polymer melts, extrusion, material physics.
- Able to build and maintain strong working relationships with people within and external to the university.
- Self-directed learner who believes in continuous learning and development.
- Proficient in communicating via technical writing and presentations.
- Possess strong analytical and critical thinking skills.
- Show strong initiative and take ownership of work.
Be The First To Know
About the latest Pharmaceutical Jobs in Singapore !
Associate Scientist/Scientist, LNP Formulation & Process Development
Posted 2 days ago
Job Viewed
Job Description
Associate Scientist/Scientist, LNP Formulation & Process Development
Posting Date : 18 Aug 2025 | Closing Date :17 Oct 2025
Job Title: Associate Scientist/Scientist, LNP Formulation & Process Development
Organization: Platform Technology
Job Type: Full Time
About NATi:
The Nucleic Acid Therapeutics Initiative (NATi), hosted by A*STAR, is Singapore's national platform dedicated to advancing RNA-based medicines and revolutionizing drug and vaccine development. NATi's mission is to establish Singapore as a globally recognized hub of excellence in nucleic acid therapeutics research, clinical translation, and commercialization.
NATi focuses on key RNA modalities such as antisense oligonucleotides (ASOs), small interfering RNA (siRNA), and messenger RNA (mRNA). To drive this vision, NATi is building a biotech-like translational engine focused on asset and technology development spanning discovery to clinical development.
We are actively seeking passionate and committed RNA scientists with deep translational expertise to join us in advancing the next generation of RNA-based therapeutics.
Position Overview
The Associate Scientist/Scientist , LNP Process Development will lead the formulation and process development of lipid nanoparticles (LNPs) for RNA delivery across multiple therapeutic programs. This role is central to NATi's translational strategy, enabling robust and scalable LNP process development and supporting clinical advancement via seamless technology transfer. The successful candidate will establish robust, scalable, and reproducible LNP manufacturing processes usingQuality by Design (QbD)principles, supporting production from early-stage research through preclinical and pilot-scale batches. The successful candidate will also drivetechnology transfer to external CDMOs, ensuring alignment with regulatory and quality standards for clinical development.
Key Responsibilities
Develop and optimize LNP formulation processes for different RNA payloads (e.g., mRNA, circRNA, saRNA, gRNA), focusing on encapsulation efficiency, particle size control, and stability.
Design and implement high-throughput, automated workflows for LNP formulation and purification, leveraging scalable technologies (e.g., microfluidics, TFF systems) to support rapid screening, process optimization, and multiscale production (mg to gram) from discovery through pilot-scale manufacturing.
ApplyQbD principlesto define critical process parameters (CPPs) and critical quality attributes (CQAs) for LNP manufacturing workflows.
Integrate process analytical technologies (PAT) for real-time monitoring and control of LNP manufacturing workflows.
Design and execute process development studies coupled with robust characterization workflows to support preclinical, toxicology, and pilot-scale manufacturing.
Collaborate with analytical teams to develop and validate methods for LNP characterization (e.g., DLS, encapsulation efficiency, TEM, HPLC).
Develop and maintain SOPs and batch records to ensure reproducibility, compliance, and readiness for GMP environments.
Maintain accurate records using LIMS/ELN systems to support data integrity and reproducibility.
Prepare technical reports, presentations, and documentation to support internal decision-making and external regulatory submissions.
Leadtech transfer activitiesto external CDMOs, including preparation of documentation, training, and troubleshooting support.
Support regulatory submissions by generating process development reports and contributing to CMC documentation.
Qualifications & Experience
MS or Ph.D. degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Material Engineering or a related field.
Minimum of 4+ (with a Ph.D. degree) or 7+ (with a MS degree) years of experience in LNP formulation and process development in pharmaceutical or biotech settings; Scientist candidates are expected to demonstrate leadership in cross-functional project teams, strategic input into platform development, and mentoring of junior staff.
Demonstrated hands-on experience in designing and implementing high-throughput, automated workflows for LNP formulation and purification, utilizing scalable technologies (e.g., microfluidics, TFF, sterile filtration) to support rapid screening, process optimization, and multiscale production.
Experience applying Quality by Design (QbD) principles in LNP process development, including the use of Design of Experiments (DoE), risk assessments (e.g., FMEA), and control strategies to define and optimize critical process parameters (CPPs) and critical quality attributes (CQAs) for scalable and reproducible manufacturing.
Proven track record of experience in regulatory filing for RNA-based therapeutics, IND-enabling CMC studies, and supporting documentation.
Experience in lyophilization process development for LNP-based formulations, including optimization of cryoprotectants, cycle design, and stability assessment is highly desirable.
A track record oftech transfer to CDMOs, including documentation and on-site support is a plus.
Strong problem-solving skills and ability to work independently and collaboratively in a fast-paced multidisciplinary environment.
Global Recruitment & Competitive Compensation
NATi is conducting a global search for top-tier talent in RNA therapeutics. We welcome applications from leading pharmaceuticals scientists and biotech innovators worldwide.
This role provides a highly competitive compensation package aligned with global industry standards, including attractive benefits and long-term career growth opportunities within Singapore's thriving biomedical innovation ecosystem. Join us in shaping the future of RNA-based medicines and establishing Singapore as a world-class hub for nucleic acid therapeutics.
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
#J-18808-LjbffrScientist/Senior Scientist, mRNA Process Development
Posted 2 days ago
Job Viewed
Job Description
Scientist/Senior Scientist, mRNA Process Development
Posting Date : 18 Aug 2025 | Closing Date :17 Oct 2025
Job Title: Scientist/Senior Scientist, mRNA Process Development
Organization: Platform Technology
Job Type: Full Time
About NATi:
The Nucleic Acid Therapeutics Initiative (NATi), hosted by A*STAR, is Singapore's national platform dedicated to advancing RNA-based medicines and revolutionizing drug and vaccine development. NATi's mission is to establish Singapore as a globally recognized hub of excellence in nucleic acid therapeutics research, clinical translation, and commercialization.
NATi focuses on key RNA modalities such as antisense oligonucleotides (ASOs), small interfering RNA (siRNA), and messenger RNA (mRNA). To drive this vision, NATi is building a biotech-like translational engine focused on asset and technology development spanning discovery to clinical development.
We are actively seeking passionate and committed RNA scientists with deep translational expertise to join us in advancing the next generation of RNA-based therapeutics.
Position Overview
The Scientist/Senior Scientist, mRNA Process Development will lead the development and optimization of scalable mRNA manufacturing processes for preclinical and clinical applications. The successful candidate will establish and optimize automated, high-throughput workflows for multiscale production of DNA templates (e.g., plasmid linearization, PCR amplification, purification) and mRNA (e.g., in vitro transcription (IVT), enzymatic processing, purification, analytical characterization, and formulation) leveraging liquid handling systems, chromatography platforms, and microfluidic technologies to support scalable and reproducible manufacturing. This role involves hands-on bench work, process innovation, and cross-functional collaboration to advance mRNA-based therapeutics across diverse therapeutic areas.
Key Responsibilities
Design and generate high-quality DNA templates for IVT process, including plasmid linearization, PCR amplification, and synthetic gene fragment assembly, ensuring optimal transcription efficiency and fidelity.
Establish and maintain robust workflows for DNA template preparation, incorporating quality control measures such as gel electrophoresis, spectrophotometry, and endotoxin removal to support scalable mRNA manufacturing.
Develop and optimize in vitro transcription (IVT) processes for multiscale mRNA synthesis, including enzymatic reactions, and yield enhancement strategies.
Establish purification workflows for mRNA using chromatography, filtration, and enzymatic treatments to ensure high purity and integrity.
Characterize mRNA drug substance using advanced analytical techniques (e.g., capillary electrophoresis, UV spectroscopy, LC-MS, bioanalyzers, qPCR).
Source, evaluate, and select critical raw materials (e.g., capping reagents, enzymes, nucleotides, buffers) required for DNA template preparation and mRNA synthesis, ensuring quality, compatibility, and scalability for research and manufacturing workflows.
Develop and maintain SOPs for mRNA synthesis, purification, and analytical characterization to ensure high quality, reproducibility, and regulatory compliance.
Collaborate with formulation and delivery team to integrate mRNA constructs into appropriate delivery systems for in vitro and in vivo studies.
Maintain accurate records using LIMS/ELN systems to support data integrity and reproducibility.
Serve as the technical lead in cross-functional teams, driving mRNA process development from early-stage research to IND-enabling studies.
Contribute to NATi's intellectual property portfolio through innovation in mRNA chemistry, process design, and analytical technologies.
Prepare technical reports, presentations, and documentation to support internal decision-making and external regulatory submissions.
Mentor junior scientists and research associates as the mRNA platform expands.
Qualifications & Experience
Ph.D. in Biochemistry, Molecular Biology, Chemical Engineering, or a related field.
Minimum of +4 (Scientist) or +8 (Senior Scientist) years of hands-on experience in mRNA process development in pharmaceutical or biotechnology settings.
Hands-on experience in DNA template design and preparation (e.g., plasmid linearization, PCR amplification), IVT reaction optimization, mRNA purification, and operation of associated equipment.
Experience with analytical tools for RNA characterization (e.g., HPLC, LC-MS, CE, UV, qPCR, gel electrophoresis).
Experience with automated platforms for nucleic acid production and purification is highly desirable.
Experience with emerging mRNA constructs such as circular RNA, self-amplifying RNA (saRNA), and other next-generation RNA formats is highly desirable.
Proven track record in mRNA-based therapeutic development, demonstrated by contribution to publications, patents, regulatory filings, or other public disclosures.
Strong problem-solving skills and ability to work independently in a fast-paced, collaborative environment while contributing to cross-functional teams by delivering on assigned scientific and operational responsibilities.
Experience working in GMP or IND-enabling environments is a plus.
Prior experience in development of mRNA-based therapeutics for infectious diseases, immunity, or genetic disorders is a plus.
Global Recruitment & Competitive Compensation
NATi is conducting a global search for top-tier talent in RNA therapeutics. We welcome applications from leading pharmaceuticals scientists and biotech innovators worldwide.
This role provides a highly competitive compensation package aligned with global industry standards, including attractive benefits and long-term career growth opportunities within Singapore's thriving biomedical innovation ecosystem. Join us in shaping the future of RNA-based medicines and establishing Singapore as a world-class hub for nucleic acid therapeutics.
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
#J-18808-LjbffrRegulatory Affairs Specialist
Posted 2 days ago
Job Viewed
Job Description
- We are looking for a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products on a global scale.Your responsibilities will include managing the submission and approval process for various applications such as Manufacturing License Application (MLA), Technical/Site Transfer Applications, and Marketing Authorisation Applications. You will also be responsible for lifecycle maintenance activities, including preparing and submitting documentation for post-approval applications like Variations, Renewals, MAH Transfers/COAs, and Labeling.In addition, you will be required to stay informed about national, European, and International guidelines/legislation to ensure compliance with regulatory processes. You will act as a liaison between the pharmaceutical company and regulatory agencies, supporting internal requests for information.To be successful in this role, you should have 5-8 years of relevant experience in Regulatory Affairs internationally, with a strong background in lifecycle maintenance. Experience with applications such as MLA, MAA, CTD, Variations, Renewals, and Labeling is essential, along with familiarity with European Regulatory Authorities.Proficiency in software packages and databases such as Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, and PromoMat is required. Strong organizational and communication skills, the ability to prioritize tasks effectively, and a track record of delivering high-quality work are also important for this role. Experience in people management/coordination and promotional/non-promotional activities would be considered a plus.,
Sign-in & see how your skills match this job
Sign-in & Get noticed by top recruiters and get hired fast
Regulatory Affairs Specialist Related Jobs #J-18808-Ljbffr