Regulatory Affairs Lead

2 days ago

Singapore ACCESS PEOPLE (SINGAPORE) PTE. LTD. Full time

**Position Overview**:
**Key Responsibilities**:

- Develop and execute regulatory strategies for product development, registration, and lifecycle management in compliance with regional and global regulations.
- Collaborate cross-functionally with internal teams including R&D, clinical development, quality assurance, and commercial departments to ensure regulatory requirements are integrated into product development plans.
- Build and maintain strong relationships with regulatory authorities in SEA countries, representing the company's interests and ensuring successful regulatory submissions.
- Stay updated on evolving regulatory requirements, guidelines, and industry trends in the SEA region to inform strategic decision-making.
- Prepare and submit high-quality regulatory submissions and respond to regulatory queries and requests.
- Lead regulatory interactions, meetings, and negotiations with health authorities to drive approvals and address any regulatory concerns.
- Manage regulatory budgets and timelines, ensuring efficient execution of regulatory plans.
- Provide regulatory input and expertise during due diligence activities for potential in-licensing opportunities and partnerships.
- Participate in global regulatory initiatives and contribute to the development of company-wide regulatory strategies and policies.

**Qualifications and Requirements**:

- Bachelor's or advanced degree in life sciences, pharmacy, or a related field. Advanced degree preferred.
- A progressive experience in regulatory affairs within the biopharmaceutical industry.
- Strong expertise in regulatory affairs specific to the Southeast Asia region, with a proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of SEA regulatory guidelines, laws, and requirements for pharmaceuticals and biologics.
- Excellent interpersonal, communication, and negotiation skills, with the ability to effectively engage with regulatory authorities and cross-functional teams.
- Strategic thinker with the ability to align regulatory strategies with overall business goals.
- Experience in interacting with global regulatory agencies.
- Proven ability to work in a fast-paced, dynamic environment, managing multiple projects and priorities effectively.

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