Key Responsibilities
- Develop and execute regulatory strategies to support product registrations and lifecycle management across Singapore and ASEAN.
- Lead preparation and submission of regulatory dossiers including NDAs, BLAs, CTAs, and CMC variations.
- Manage post-approval activities such as label updates, safety variations, renewals, and regulatory commitments.
- Act as the primary liaison with Singapore regulatory authorities, supporting agency interactions, audits, and inspections.
- Provide regulatory guidance to cross-functional teams including Medical Affairs, Safety, Market Access, Quality, and Commercial.
- Review scientific data packages and identify regulatory gaps, risks, and mitigation strategies.
- Collaborate with regional regulatory teams and external distributors on assigned projects.
Requirements:
- Degree in Pharmacy
- Registered Pharmacist with the Singapore Pharmacy Council (SPC).
- 5–8+ years of Regulatory Affairs experience, including at least 4 years in Singapore.
- Strong experience in oncology product submissions and biologics (NDAs/BLAs).
- Familiarity with HSA regulations and ASEAN regulatory requirements.
- Experience managing regulatory submissions and authority interactions across the region.
- Strong stakeholder management, analytical, and communication skills.
If you are a regulatory professional looking to take on the next challenge, feel free to reach out for a confidential discussion or apply directly.
Please note that applicants should already have the legal rights to work in Singapore as this role does not provide work pass sponsorship.
Reg. No. R1110770
BeathChapman Pte Ltd
Licence no. 16S8112
