Head of RA, Singapore
Head of RA, Singapore
Singapore - Singapore
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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 provide regulatory support on new product development program for product pipeline expansion in Singapore.
Essential Duties and Job Functions *
Being the regulatory lead for Singapore, the professional will fulfill regulatory responsibilities including but not limited to:
- Fulfill responsibilities as the pharmacist for the Singapore affiliate and hold necessary licenses.
- 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
- Provide management support to local regulatory lead for Cell Therapy Program in Singapore
- Independently manage regulatory submissions, including CTA and NDA filings and obtain timely approval
- 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.
- Maintain the necessary licenses, e.g. importer and wholesaler licenses
- Maintain product registration certificates by timely submission and approval of variations and renewals
- Manage 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.
- Fulfill local QA and pharmacovigilance 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 *
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 minimal supervision of a senior Regulatory Affairs professional.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Singapore---Singapore/Assoc-Director--Regulatory-Affairs_R0023022-1
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