Senior Manager, International Regulatory Affairs

2 weeks ago

Singapore beBeeRegulatory Full time $90,000 - $120,000

At Gilead, we create a healthier world for all people by working together to develop life-changing scientific innovations.

Job Overview

The Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs International Affiliate Team is seeking a skilled regulatory professional to join our diverse team.

This full-time position is based in Singapore and primarily focuses on CMC activities in Australia and New Zealand.

Key Responsibilities:
  • Design and execute CMC RA strategies that align with business goals in collaboration with global teams.
  • Ensure CMC regulatory submissions meet ICH and regional/local regulatory requirements.
  • Plan, author, and submit CMC regulatory submissions, including clinical trial applications, amendments, supplements, marketing authorizations, post-approval variations, periodic reports, and license renewals.

As a key driver of our culture, you will evolve our work environment to foster inclusivity, development, and empowerment among employees. Your successful candidate will contribute to the success of the organization through effective communication, negotiation, and influencing skills with cultural sensitivity.

Required Skills and Qualifications:

Essential Skills:
  • Ability to develop and implement regulatory strategies.
  • Strong organizational skills and ability to manage multiple products/markets with tight timelines.
  • Excellent communication, negotiation, and influencing skills with cultural sensitivity.
Qualifications:
  • Scientific degree with at least 8 years of relevant experience or 6 years with an MSc, preferably in small molecule CMC regulatory activities; biologics experience is a plus.
  • Fluent English speaker with practical knowledge of ICH, EU, and Australian CMC regulatory requirements.
Preferred Experience:
  • Regulatory submissions, including marketing authorizations and variations, especially in Australia/New Zealand.
  • Cross-functional teams and managing health authority interactions, with TGA experience being advantageous.
  • Drug-device combination product experience is a plus.

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