Associate Director, Regulatory Affairs
2 days ago
For Current Gilead Employees and Contractors:
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
**Job Description**:
Specific Responsibilities and skills for Position *
This position will report to the Head of Regulatory Affairs, Hong Kong/ Singapore/ Malaysia, based in Hong Kong and act as the regulatory head of Singapore.
Essential Duties and Job Functions *
Being the regulatory head for Singapore, the professional will fulfill regulatory responsibilities including but not limited to:
- Fulfill responsibilities and be accountable as the Responsible Person for the Singapore affiliate and hold necessary licenses including Wholesaler and Importer licenses, and ensure compliance with local GDP requirements.- Provide regulatory strategic input for product development program to drive rapid product registration approvals- Act as main contact and manage negotiations with regulatory authorities- Act as consultant to local affiliate, regional, international or global RA teams on affiliate matters- Manage Singapore RA team including local regulatory lead for Cell Therapy Program in Singapore- Independently manage regulatory submissions, including CTA and NDA filings and obtain timely approval- Maintain product registration certificates by timely submission and approval of variations and renewals- Assist in planning, preparation and compilation of dossiers in ASEAN common technical document (CTD) format or ICH CTD format to ensure timely approvals of IND, NDA, variations etc.- Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.- Coordinate with CRO for timely completion of clinical/regulatory projects when needed- Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses and follow up on new packaging implementation.- Ensure regulatory/legal compliance of regulatory activities- Provide regulatory support to ensure compliance on business practice, e.g. promotional material review and approval, development of system / SOPs as necessary- Maintain RA database, records and archives regulatory documentation
Knowledge, Experience and Skills *- A registered pharmacist in Singapore with strong technical experience in Regulatory Affairs.- Minimum 10 years of relevant experience in Regulatory Affairs for Singapore.- Previous people management experience is desirable.- Experience in working and leading cross-functional project teams.- Excellent organization skills, strong attention to detail and ability to work on a number of projects with tight timelines are required.- Excellent verbal and written communication skills and interpersonal skills are required.- Good team player.- In-depth knowledge of regulatory requirements, including ICH requirements.- Is recognized as a knowledgeable resource within the department.- Work is performed under mínimal supervision of a senior Regulatory Affairs professional.
For Current Gilead Employees and Contractors:
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