Associate Director, International CMC

This position will be responsible for execution and management of regional life-cycle submissions for all products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

The Regulatory CMC Regional Hub is a key component of strategy to build regional regulatory knowledge, effective local relationships with country offices in order to deliver appropriate regulatory strategies and right first time regulatory submissions and support conformance of manufacturing practices with registered details.

Responsibilities:
* The incumbent will be the primary regulatory (CMC) point of contact for the Regional/Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the CMC product managers and the Regulatory network.
* In coordination with global CMC Regulatory leaders, execute regulatory strategy for lifecycle submissions in the specified regional markets, for management of CMC changes originating at manufacturing sites or affiliates by maximizing submission efficiency and quality to ensure a high rate of submission approvals by Health Authorities.
* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions; coordinate/manage with affiliates the timely and effective submission of changes to the Health Authorities.
* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.
* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.
* Coordinate strategic planning with Regional Supply Chain and Affiliate DRAs for change management alignment and early visibility/communication/planning of changes impacting markets in the region.
* Manage tracking of Health Authority commitments as result of license/dossier approval and ensure commitment due dates are met.
* Ensure timely update of the CMC change management electronic systems, using the regulatory information provided from the submission/approval externally by a Health Authority, or internally by the appropriate functional area.
* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).
* The candidate may be required to travel to other sites on a periodic basis.

If you are interested in discussing further on the opportunity in a confidential manner, or other Regulatory Affairs opportunities in the pharmaceutical and medical devices industry, please contact Jennifer Ha at j.ha(@)realstaffing.com or contact +65 6871 4700.

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:
International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Gloabl Recruiters 2017

Application Email: JIHA.05071.3273@sthreesg.aplitrak.com