Manager/Sr Manager, Regulatory Affairs CMC

Manager/Sr Manager, Regulatory Affairs CMC
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination, and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations. Join Gilead and help create possible, together.
Job Description
The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware regulatory professional to join our diverse, globally dispersed team. This full-time position is based in Gilead's Singapore office and is for the role of
CMC Regulatory Affairs (Senior) Manager . The successful candidate will report to the CMC Regulatory Affairs International Affiliate Team Leader and will primarily be responsible for CMC activities in Australia and New Zealand.
Job overview/summary
CMC Regulatory Affairs (Senior) Manager
serves as the CMC RA Affiliate for assigned products and territories, designing and executing CMC RA strategies that align PDM's (Pharmaceutical, Development, Manufacturing) CMC objectives with Affiliate's business goals, in collaboration with global teams.
Job responsibilities
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.
Lead discussions and negotiations with health authorities regarding CMC questions, ensuring responses are consistent and aligned with ICH and TGA guidelines.
Manage document filing, retrieval, and dissemination functions following SOPs and work instructions.
Assess CMC change controls against local regulations and best practices.
Collaborate with cross-functional teams to define strategies and filing plans, anticipating regulators' questions and responses.
Contribute to global filing strategies, providing local/regional expertise and innovative, risk-based approaches.
Support regulatory intelligence activities to stay abreast of CMC registration requirements and best practices.
Ensure regulatory conformance and consistency for assigned products and communicate changes affecting labeling.
Participate in or lead updates related to legislation changes and may support training or serve as a global project lead.
Skills and Competencies
Ability to develop and implement regulatory strategies, author, and coordinate CMC regulatory documents.
Strong organizational skills and ability to manage multiple products/markets with tight timelines.
Excellent communication, negotiation, and influencing skills with cultural sensitivity.
Critical and strategic thinking to address current and future challenges.
Ownership mentality and networking skills.
Cultural awareness and ability to work with diverse teams.
Adaptability, resilience, and independence in work approach.
Knowledge and Qualifications
Scientific degree with at least 8 years of relevant experience (BSc) or 6 years (MSc), preferably in small molecule CMC regulatory activities; biologics experience is a plus.
Fluent in English, with practical knowledge of ICH, EU, and Australian CMC regulatory requirements.
Experience with regulatory submissions, including marketing authorizations and variations, especially in Australia/New Zealand.
Experience in cross-functional teams and managing health authority interactions, with TGA experience being advantageous.
Drug-device combination product experience is a plus.
Additional Information
For current Gilead employees and contractors: Please apply via the Internal Career Opportunities portal in Workday.
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