59 Regulatory Affairs Associate jobs in Singapore

Job Description & Requirements

Reporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation.

Responsibilities

· Assist with submission of applications and variations for clinical trials and marketing authorisation across all pipelines

· Support regulatory assessment of submission requirements based on relevant regulations

· Assist with administrative work necessary to support regulatory activities

· Review and provide input for regulatory documents

· Support any other duties assigned

Qualifications

· Degree in Biological, Chemistry, or a related field

· No experience required. Must have an interest in Regulatory Affairs

· Keen learner with a strong attention to detail and organizational skills

· Proficiency in English (written and spoken) is required

• Ensure products delivered meet legal and customers' requirements
• Drive the quality improvement programs and activities and seek for continuous improvement.
• Deal with process quality issues; and deal with customers' quality issues & enquiries.
• Monitor GMP & QA activities of the company for regulatory compliance
• Outline quality assurance policies and procedures
• Interpret and comply with quality assurance standards
• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies
• Participates in Regulatory and Customer Audits.
• Oversee the implementation and ensure efficiency of inspection and quality systems
• Document quality assurance activities, such as internal audits
• Analyze customer grievances and other non-compliance issues
• Providing training for employees to ensure compliance with SOPs
• Analyze audit outcomes and carry out appropriate corrective procedures
• Set up and maintain pharmaceutical and medical device quality system in accordance with the company's quality policy
• Maintain a good documentation system for organizing controlled documents and retaining records of manufacture which enable the complete history of a batch to be traced, readily available and easily traceable
• Ensure established Quality Management System such as Product Complaint & Recall, Internal &External Audits, Vendor Management, Deviation Management, CAPA, Change Control and Quality Risk Management are effectively implemented, monitored and in compliance with cGMP / authority requirements

• Lead the formulation of registration strategy for products/projects. Ensures effective implementation of the strategies and adhere to corporate objectives and business goals.
• Regulatory knowledge: Maintains a high level of regulatory knowledge on global/regional regulatory requirements and provides regulatory guidance for global counterparts.
• Agency interactions: Acts as core point of contact to relevant authorities/external organizations (CROs, NBs, etc) for products/projects. Liaises, negotiates and lead interactions, including appropriate documentation of the interaction, decisions and outcomes.
• Dossier submissions: independently leads the preparation, coordination or monitoring or regulatory submissions. Interacts across APAC and global to obtain and/or provide information/data for regulatory submissions.
• Coordinates change control responses from APAC countries and stock build if required with supply chain department.

• Conduct in-depth geopolitical analysis, assessing risks and opportunities for investors across Southeast Asia and global markets.
• Engage with local organizations, policymakers, and experts to gather real-time insights.
• Produce high-quality written reports and investment recommendations.
• Deliver high-level presentations in Mandarin to clients, internal teams, and senior leadership.
• Collaborate with CGS Research and other internal teams to align geopolitical insights with market strategy.
• Monitor regulatory and political developments, ensuring compliance with local and group policies.
• Present findings to institutional investors, asset managers, and corporate clients.

• Regulatory matters: Local Head of Research (HOR)
• Functional matters: Group Head of Research
• Collaboration: Close coordination with CGS Research team

• Strong understanding of Southeast Asian and global political-economic landscapes.
• Fluency in Mandarin (written and spoken) for high-stakes presentations and client engagement with our Chinese counterparts
• Excellent research, analytical, and communication skills.
• Ability to travel within the region for fieldwork and stakeholder meetings.
• >5 years of experience in geopolitical analysis, political risk, or international relations, preferably within financial services.
• Leadership, collaborator, independence, integrity, good communicator
• At least a Bachelor Degree

We are currently seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Singapore.

1. Efficiently manage and successfully execute all aspects of global start-up;
2. Perform quality checks on submission documents and site essential documents;
3. Prepare and approve informed consent forms;
4. Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
5. Present during bid defenses, general capabilities meetings, and audits.

1. More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
2. Regional experience will be highly advantageous;
3. Strong oral and written communication skills.

Travel: Minimal

Job Title: Legal Assistant

We are seeking a skilled and detail-oriented Legal Assistant to join our team. As a Legal Assistant, you will provide administrative support to our lawyers, including filing, calendar management, and e-filing of documents.

• Provide full legal secretarial services/paralegal assistance, and administrative support to lawyers.
• Liaise with clients, file documents, manage calendars, and perform e-filing tasks.
• Assist with legal research, drafting court documents, and preparing bundles for hearings.

• Diploma in Law or relevant experience in law firms.
• Ability to work under pressure, multitask, and maintain attention to detail.
• Excellent communication and interpersonal skills, with the ability to work as part of a team.
• Proficiency in Microsoft Office applications, particularly Word, Excel, and PowerPoint.
• Good command of spoken and written English, with the ability to draft clear and concise documents.

• The opportunity to work in a dynamic and supportive team environment.
• A competitive salary package and benefits, including opportunities for professional development.
• The chance to develop your skills and expertise in a fast-paced legal environment.

Please send your resume with all relevant details to us via email.

The Opportunity

• This is an exciting opportunity to work for one of the public sector organisations
• This will start off as a 8 months contract

Responsibilities

Operations

1. Review documents in trade mark disputes

2. Draft and issue letters to parties in trade mark disputes

3. Support team in the procedures of trade mark disputes

Administrative Support for Promotion of IP/Tech Dispute Resolution

1. Research possible flights, hotels and restaurants for US trip

2. Book flights and hotels; make reservations at restaurants; for US trip

3. Set up RSVP system for different events, coordinate and follow up

4. Create and update administrative programme for US trip

5. Format PowerPoint presentation slides

6. Publish email updates to subscribers

Requirements

· Self-driven and motivated

· Meticulous and systematic

· Able to write and communicate clearly in English

· Able to work well independently and within a team

· Knowledge of intellectual property, especially the procedures of trade mark disputes, is a plus

· Bachelor university degree or polytechnic diploma with commendation, in any discipline

· Microsoft Office (There will be on-the-job-training on other IT applications used in the job)

· Work experience, especially in the legal field, is a plus

Next Steps

• Drop your resume and contact us to follow-up, or send your resume to
• Email Topic: Legal Assistant
• All shortlisted candidates will be contacted

Amos Tan Jun Han

EA Licence Number: 91C2918

Personnel Registration Number: R23113385

Hogan Lovells is a leading global law firm known for its exceptional breadth of practice, deep industry knowledge, and 'one team' approach. Our distinctive market position enables us to provide clients with a wide range of services across various streams.

We are seeking a skilled professional to join our Banking practice in Singapore. This role offers the opportunity to work on structuring and executing transactions around the region and globally. We value our ability to provide practical commercial advice and bring local expertise to each financial centre we operate in.

• Assist with legal matters including post-closing activities and document formatting
• Draft straightforward contracts and conduct research tasks as needed
• Carry out due diligence procedures and maintain attention to detail
• Work collaboratively as part of a team to achieve shared goals

Equal Opportunities Policy

Hogan Lovells is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, age, national origin, disability, sexual orientation, gender identity or expression, marital status, genetic information, protected veteran status, or other factors protected by law.

• Manage corporate expansions, liquidations, integrations and coordination of corporate compliance, governance and maintenance for Alphabet subsidiaries in the APAC region.
• Plan and coordinate board/shareholder meetings in accordance with local statutory and regulatory requirements, including attending meetings, preparing board/shareholder documents, taking minutes, maintaining corporate records and internal databases. Monitor and handle required corporate and regulatory filings.
• Help prepare preliminary drafts of legal documents and process documentation, and lead training sessions internally.
• Ensure compliance to processes and procedures, provide guidance to ensure conformity and consistency in the application of Alphabet's policies/practices. Perform corporate housekeeping tasks, including tracking of documents, routing documents for signature and distribution, filing, data organization, and managing logistical matters such as corporate chopping, certification etc.

• Bachelor's degree or equivalent practical experience.
• 5 years of legal work experience in a law firm, government, or in house legal department.
• Qualified Company Secretary or Paralegal.

• Ability to work on legal and non-legal matters.
• Excellent communication and collaboration skills, with the ability to build relationships across the business at all levels.
• Excellent problem-solving skills, with the ability to review and organize numerous documents in legal matters.
• Excellent organizational skills, time management, and attention to detail with the ability to handle the environment and prioritize multiple projects/requests that are time sensitive.
• Excellent team player with commitment to professionalism and collegiality as part of a performing team.