Regulatory Affairs Specialist (CMC/ Contract/ City)

Location Singapore, Singapore
Discipline Pharmaceutical
Job Reference BBBH83978_1573458903
Salary Negotiable
Consultant Name Ng Yew Koon, Sherry
Consultant Email
Consultant Contact No. 62328834
EA License No. 02C3423
Consultant Registration No. R1657259

Regulatory Affairs Specialist (CMC/ Contract/ City)


Maintain the product licences in compliance with the local requirements:

  • Life Cycle management: preparation of the Module 3 CTD dossiers as per the applicable regulation for renewals, new registrations, responses to the Health Authorities
  • Regulatory Compliance: gap analysis V.S the current dossiers and V.S the current ICH/ASEAN Guidelines
  • Regulatory variations preparation by using the regulatory tool Domasys.
  • Change Control management: preparation of change control request form (CCRF), quality/regulatory assessment.
  • Elaborate the regulatory strategy with Global Regulatory Affairs and local affiliates.
  • Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
  • Make quality regulatory decisions, balancing risks and benefits.
  • Coordinate with Global Regulatory Affairs CMC, affiliates, local Regulatory Affairs to ensure timely and accurate submissions to Regulatory Authorities.

Key-point for all CMC RA topics within the scope transfer project

  • Collect the registered information from all markets
  • Collect the site documentations (batch records, QC working instructions, stability reports, batch analysis ) from the sending site necessary to perform the gap analysis.
  • Identify as early as possible, the required documentation and any content, quality and/or time-line issues. Negotiate the delivery of approved technical source documents in accordance with project time-line.
  • Perform the variation record card (VRC): gap analysis of the current dossier V.S the donor site V.S the receiving site.
  • Consolidate the regulatory strategy with the affiliate or the Global RA to submit the site change
  • Coordinate with the receiving site the specific activities to fulfil the requirements for each market such stability studies, dissolution, BE study, etc..
  • Preparation of the CMC sections based on the documents provided by the third party manufacturer
  • Formatting of the CMC modules as per the corporate requirements and creation of the CTD documents in Domasys
  • Response to MoH questions related the quality module of the dossier
  • Follow up of the regulatory status of the submissions.
  • Provides RA CMC support to other corporate sites who will receive the products from third party manufacturer
  • Provide regulatory training to the toll manufacturers
  • Provide regulatory KPI's and regulatory highlights to the reporting manager on a monthly basis
  • Any Ad Hoc activities as specified by the Reporting Manager


  • At least 3-5 years working experience in CMC regulatory affairs in drug products (finished products).
  • Record of achievement of regulatory approvals and demonstrated success in working with toll manufacturers.
  • In depth knowledge of ASEAN Guidelines Regulatory and pharmaceutical issues and ICH guidelines
  • CMC support of new pharmaceutical and/or marketed pharmaceutical products in Asia.
  • Ability to provide input, guidance and recommendations in the preparation of the dossiers from different sources to give uniformity of filing in each country.
  • Process oriented and very good at data management
  • Capable of interacting with the other regulatory departments and other EM counterparts (Quality, Supply chain).
  • Technical knowledge for various non-sterile dosage forms and APIs
  • CMC support of new pharmaceutical and/or marketed pharmaceutical products in Asia.
  • Ability to work in a matrix organization.
  • Possess a Degree in Pharmacy / Pharmaceutical Science / Related Science from a recognized institution.

If you have the relevant skillsets, please send in your updated CV in word format to or click on "APPLY NOW".

We regret only shortlisted candidates would be contacted.

Sherry, Yew Koon Ng EA License No.: 02C3423 Personnel Registration No.: R1657259

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