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 sherry.ng@manpower.com.sg
Consultant Contact No. 62328834
EA License No. 02C3423
Consultant Registration No. R1657259


Regulatory Affairs Specialist (CMC/ Contract/ City)

Responsibilities

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

Requirements:

  • 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 sherry.ng@manpower.com.sg 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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