Manager, Regulatory Affairs

2 weeks ago

Singapore Gilead Sciences Full time

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, Singapore, based in Singapore and provide regulatory support on product development program for product pipeline expansion in Singapore, primarily focusing on Oncology products.

Essential Duties and Job Functions *

The professional will fulfill regulatory responsibilities including but not limited to:
- Independently lead and 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.- Act as main contact and manage negotiations with regulatory authorities.- Act as a consultant to local affiliate, regional, international or global RA teams on local regulatory matters.- Provide regulatory strategic input for product development program to drive rapid product registration approvals.- Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements based on Singapore regulations, regional requirements and scientific and company policies and procedures.- Establish and maintain the necessary licenses to support business, e.g. Dealers’ License.- 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.- Fulfill local PV and QA responsibilities.- 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 *- University graduate in Life Sciences or Pharmacy (preferably registered pharmacist in Singapore).- Minimum 6 years of relevant experience in Regulatory Affairs for Singapore.- Experience in oncology products is a must.- 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 and excellent cross-function collaboration.- In-depth knowledge of regulatory requirements, including local and international requirements (e.g. 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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