6months Regulatory Affairs Specialist ($7K to $9K)
The primary function of the Specialist, Regulatory Affairs (RA) is to act as the representative of the regulatory affairs organization to the commercial organization for all aspects related to the assigned therapeutic area and products of responsibility. The incumbent will have knowledge of the regulatory requirements of the countries within the region.
- Manages interface with Affiliate/Agency for key projects/issues, including direct/indirect negotiation with regulatory agencies.
- Implements regulatory strategies for assigned projects for countries area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
- Partners with commercial area to ensure business needs are met.
- Represents the regulatory function at sub-teams or client group meetings (i.e. commercial R&D, CMC, GPO, etc.) to present regulatory requirements or provide strategic input for the registration of products.
- Assesses scientific data provided by specialist units for registration purposes against national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
Education / Experience Required:
- Min BS degree in pharmacy, pharmacology, biology or related subject.
- Minimum 5 years’ experience in Regulatory in pharmaceutical
- Able to start work immediately or short notice
Salary range: $7K to $9K
Pharmaceutical US MNC
Interested candidates, please forward your resume to [Click Here to Email Your Resume]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
Recruit Express Pte Ltd