357 Regulatory Affairs Manager jobs in Singapore

• Opportunities for professional development
• Reputable organization
• Good company benefits

As an Regulatory Affairs Manager (Chinese Proprietary Medicine), you will be responsible for the following duties:

• Serve as the primary point of contact between the company and regulatory authorities (e.g., Health Sciences Authority) to oversee and support product registration, certification, and application processes for market entry. Ensure ongoing license maintenance (e.g., Marketing Authorizations) aligns with local regulatory requirements and that corporate regulatory systems, SOPs, and procedures are effectively implemented.
• Compile and organize technical documentation, product details, and ensure all materials related to product registration, manufacturing, and marketing adhere to Singapore's regulatory standards.
• Build and maintain strong working relationships with key external regulatory agencies; coordinate and attend meetings, and engage in regulatory negotiations as needed.
• Manage and ensure regulatory compliance for pharmaceutical exports from China to Singapore in accordance with relevant export regulations.
• Support internal teams by conducting research and evaluation of proprietary Chinese medicine formulas, and provide regulatory insights and consultation.

Requirements:

• Master's degree or above in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, or a related field.
• At least 5 years of working experience is required, with 2 years of drug registration experience.
• Preferably a registered pharmacist with the Singapore Pharmacy Council, would be advantageous. Proprietary Chinese medicines is preferred.
• Proven ability to manage regulatory issues.
• Knowledge of regulatory environment and how this impacts regulatory strategy and implementation.
• Knowledge of drug development practice, rules, regulations and guidelines.

To apply, simply click on the "apply" button in the job advertisement or alternatively, you can send in your resume via email: .COM.SG

We regret to inform that only shortlisted candidates will be notified.

ALLIED SEARCH PTE. LTD.

EA LICENSE : 19C9777

• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Participate in the development or implementation of clinical trial products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities.
• Provide responses to regulatory authority regarding product information or issues.
• Review all regulatory authorities' submission materials to ensure timeliness and accuracy.
• Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.

Salary Range MYR 7,000 - 7,999
City Bandar Sri Damansara
Country Malaysia
Job Description
Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
Ensure compliance with advertisement and labeling regulations in each marketing territory.
Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
Plan and lead the implementation of internal RA audits on an annual basis.
Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
Support regulatory matters related to custom import requirements and documentation.
Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.
Requirements
Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.
Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers,effectively.
In-depth knowledge and hands-on experience in medical device registration and regulatory compliance, particularly in Malaysia, Singapore, and Indonesia.
Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
Meticulous and detail-oriented, capable of working independently with minimal supervision.
Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
Pharmacist background with a valid license will be an added advantage.
#J-18808-Ljbffr

Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures.
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met.
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
Participate in the development or implementation of clinical trial products.
Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities.
Provide responses to regulatory authority regarding product information or issues.
Review all regulatory authorities’ submission materials to ensure timeliness and accuracy.
Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.
#J-18808-Ljbffr

• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Participate in the development or implementation of clinical trial products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities.
• Provide responses to regulatory authority regarding product information or issues.
• Review all regulatory authorities’ submission materials to ensure timeliness and accuracy.
• Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.

Coordinate product registration in designated countries by preparing dossiers and obtaining certificates within specified timeframes.

Act as a liaison between factories and regulatory teams of designated countries to ensure seamless collaboration.

Provide regulatory assessments for new products and change introductions to ensure compliance.

Offer expert advice on interpreting relevant guidance documents and standards to internal and external teams.

Support the preparation of tender submission documents to facilitate successful project implementations.

Perform other duties assigned by superiors to drive business growth and development.

• Bachelor's degree in a relevant field such as life sciences, chemistry, or engineering.
• A minimum of three years' experience in a relevant field with a proven track record of success.

This role offers opportunities for career advancement and professional growth in a dynamic industry.

Collaborate with experienced professionals to develop your skills and expertise.

Enjoy a comprehensive benefits package including health insurance, retirement plans, and paid time off.

We are a leading company in the industry, dedicated to delivering innovative solutions and exceptional customer service.

Our team is passionate about making a difference and strives to exceed expectations.

We value diversity, equity, and inclusion, and are committed to creating a workplace that reflects these principles.

Primary Function
职责概述
To operate the registration in compliance for China and select countries in Asia Pacific region
To ensure the registration schedule to meet the business development requirement
Major Responsibilities
主要职责
Lead and complete regulatory registrations to ensure shipment of product within the Asia Pacific region.
Be responsible for registration projects for the designated countries in the region.
Solve requests for additional information and issues/questions from regulatory agencies and governments to meet submission requirements.
Ensure that new registration projects are scheduled and that we achieve the expected schedule.
Ensure the renewal license and change application on time.
Provide regulatory intelligence updates for regulations, standards and guidance documents to ensure that the organization takes actions to remain compliant.
Provide the requested explanation for regulatory changes and any applicable training to global or local cross group if necessary, from regulatory side.
Communicate with cross functional teams such as Quality Assurance, R&D, Marketing, Operations and others as required to ensure that complete and accurate information is submitted for submissions and that regulatory requirements are communicated to the organization.
Assist to ensure that the registration procedures and SOPs are clear, concise and aligned with current practices and requirements.
Provide related regulatory support to other company personnel.
Develop and maintain good relationships with related authorization agencies and relevant industry association to build advocacy.
Requirement(education, background,.etc)
要求
Bachelor’s degree or above
Above 10 working experience and minimize 2 to 4 years of relevant RA management experiences
Good English speaking and written and communication skills.
#J-18808-Ljbffr

Basic Functions:

• Oversee the quality assurance program to ensure product quality and compliance.
• Implement and maintain the Quality Management System (QMS).
• Manage worldwide product registration, licensing, and regulatory compliance.

Key Responsibilities:

• Ensure proper implementation and maintenance of QMS and Quality Control procedures.
• Provide direction on quality matters, ensuring compliance with regulatory requirements.
• Maintain document control for product specifications, manuals, and quality records.
• Oversee product and process validation to demonstrate compliance and capability.
• Ensure effective implementation of corrective actions for quality issues.
• Conduct quality system reviews to maintain compliance with required standards.
• Manage regulatory documentation for worldwide product registration, including US FDA, CE marking, and IVD regulations.
• Identify training needs, set department objectives, and oversee staff responsibilities.
• Approve Certificates of Analysis and Certificates of Origin.

Requirements:

• Bachelor's degree in Biotechnology, Biology, Biomedical Sciences, or a related scientific discipline, or an equivalent qualification.
• Preferably 5 years of experience in Quality Assurance, Regulatory Affairs, and Compliance within the biomedical, in-vitro diagnostics, medical devices or related industry.
• Strong expertise in QMS, ISO standards, GMP, MDSAP, and global regulatory frameworks.
• Proficiency in regulatory documentation and compliance processes.
• Strong analytical skills with the ability to collaborate across teams and regulatory bodies.

Who We Are
We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us

What The Regulatory Affairs Department Does At The Worldwide
Regulatory Affairs plays a pivotal role in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations. Their expertise drives the development and approval of innovative medical products, supports business development efforts, and offers strategic guidance on contract negotiations. They also mentor junior staff, review key documentation for global regulatory standards, and keep all stakeholders informed throughout the submission process

What You Will Do

• Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
• Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
• Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements
• Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff

What You Will Bring To The Role

• Clearly, proven leadership and organizational management skills are essential attributes
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Excellent written and verbal communication skills to clearly and concisely present information
• Relationship-building competency combined with demonstrated comfort supporting Business Development at a face-to-face meeting
• Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

Your Experience

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR:
• Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years of experience within clinical research (e.g., CRA, Reg Affairs).
• Minimum 5 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience across the APAC region
• Proficient in cross-cultural communication and proficient in both spoken and written English

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide For more information on Worldwide, visit or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law
.