Regulatory Affairs Manager

About the role

The Regulatory Affairs Manager will lead all regulatory activities for Takeda's products in Singapore, ensuring compliance with statutory and company requirements while supporting business objectives.

Key responsibilities

• Plan, strategize and monitor regulatory filings for new product registrations and variations.
• Manage the product lifecycle, including labeling changes, safety updates, and artwork development/approval.
• Build and maintain effective relationships with the Singapore regulatory agency and pharmaceutical associations.
• Collaborate with local functions to develop regulatory strategies that support commercial goals and product launches.
• Develop the annual regulatory budget for filings, variations, registrations and license renewals.
• Review promotional material and support ad‑hoc regulatory requests for partner products.
• Maintain local and global regulatory databases and track policy changes.
• Participate in authority inspections and internal audits.
• Act as the Responsible Person for Takeda Pharmaceuticals Asia Pacific, ensuring compliance with GDP standards.

Required profile

• Registered Pharmacist in Singapore.
• Bachelor's degree in Pharmacy.
• 5–7 years of experience in regulatory affairs within the pharmaceutical industry.

Required skills

• Regulatory filing and submission expertise.
• Labeling and artwork management.
• Good Distribution Practice (GDP) knowledge and training.

What we offer

• Opportunity to influence regulatory strategy for a leading global pharma company.
• Collaborative environment with cross‑functional teams.
• Professional development and career growth in Singapore.