Location: Central
Salary: Up to $10000 depending on your experience
Annual Leaves / Medical Leaves
Bonus / VB
Career Advancement

Our client, a leading MNC company in Pharmaceutical Industry located in the Central is currently looking for CMC Regulatory Affairs Manager.

Responsibilities:

• 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 Veeva.
• 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, company affiliates local Regulatory Affairs to ensure timely and accurate submissions to Regulatory Authorities.
• 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 timeline.
• 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 company 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.
• Provide regulatory training to the third-party manufacturers.
• Provide regulatory KPI's and regulatory highlights to the reporting manager monthly.

Requirements:

• At least 8 years working experience in CMC regulatory affairs.
• Degree in Pharmacy / Pharmaceutical Science / Related Science
• Ability to work in a matrix organization.

• Ability to establish and maintain good regulatory networking internally and externally.
• In depth knowledge of ASEAN, ICH Guidelines and local market regulations.
• CMC support of new and/or marketed pharmaceutical/nutraceutical/cosmetics products in Asia and ATME.
• Computer skills: Word, Excel and Veeva systems (Regulatory tool for Dossier management, Registration database).

If you possess above relevant skillsets, please send in your updated CV in word format to Apple.lim@manpower.com.sg

Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup's Global Privacy Policy, please visit https://www.experis.com.sg/privacy-policy