Regulatory Affairs Specialist (Medical Device / Pharma) - $4K to $7K

Recruit Express Pte Ltd| Date Posted: 30-Dec-2020
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Permanent, Contract
Position Level:
Experienced, Manager
Bachelor's / Honours

Job Description

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. 

Major Responsibilities:

  • 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 or Medical device
  • Able to start work immediately or short notice 

Salary range: $4K to $7K

Pharmaceutical or Medical Device MNC 

Interested candidates, please forward your resume to [Click Here to Email Your Resume] 

Consultant: Huang Jingsheng Kevyn (R1333338) 

Recruit Express Pte Ltd (99C4599) 

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