Job Description
Integrity Partners Pte. Ltd. is seeking a Senior Regional Regulatory Affairs Executive to lead regulatory strategy and submissions across the Asia‑Pacific region for a fast‑growing pharmaceutical MNC. In this role, you will ensure compliance with local and international regulations, drive product registrations, and partner with cross‑functional teams to accelerate time‑to‑market while upholding the highest standards of quality and safety.
You will benefit from a collaborative culture, continuous learning opportunities, and the chance to shape regulatory pathways for innovative therapies. The position offers exposure to a diverse portfolio of products, from small‑molecule drugs to biologics, and the ability to influence regional regulatory policy through engagement with health authorities.
If you are passionate about navigating complex regulatory landscapes and making a tangible impact on patient health, we invite you to apply and join a team that values integrity, innovation, and excellence.
Responsibilities
- Develop and implement regional regulatory strategies aligned with corporate objectives and local agency requirements.
- Prepare, review, and submit regulatory dossiers (CTD, eCTD) for new product registrations, variations, and renewals across ASEAN markets.
- Act as the primary liaison with health authorities (HSA, FDA, EMA, etc.) to facilitate timely approvals and address queries.
- Monitor changes in regulatory guidelines and assess impact on product portfolios, advising business units on necessary actions.
- Provide regulatory input during product development, lifecycle management, and post‑approval activities to ensure compliance.
- Lead cross‑functional project teams, coordinating with R&D, clinical, quality, and commercial functions to meet timelines.
- Maintain accurate regulatory documentation and tracking systems, ensuring audit readiness.
- Mentor junior regulatory staff and promote continuous improvement of regulatory processes.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
- Minimum 5‑7 years of regulatory affairs experience in the pharmaceutical industry, preferably with regional or global scope.
- In‑depth knowledge of ASEAN regulatory frameworks (HSA, BPOM, TFDA, etc.) and familiarity with ICH guidelines, CTD/eCTD formats.
- Proven track record of successful product submissions, variations, and renewals across multiple jurisdictions.
- Strong project management skills with ability to prioritize tasks and deliver results under tight deadlines.
- Excellent communication and interpersonal skills, capable of influencing stakeholders at all levels.
- Detail‑oriented with high analytical ability and problem‑solving mindset.
- Familiarity with electronic publishing tools and regulatory information management systems is a plus.