Associate Director RA - Biologics & Vaccines

Directly reporting into the RA Director, APAC - this role is a broad role encompassing all aspects of regulatory strategy to support countries in region, including clinical, CMC and risk management requirements, and oversight of strategic regional labeling issues.

In this role, the regional liaison has responsibilities including:
* Serves as single POC for Vaccines and Biological Products
* For Vaccines and Biological products creates and maintains a database of country requirements for health authority registration/approval.
* Supports and provide regionally focused strategic input to product development across region and across portfolio.
* Contributes to region specific aspects of a development strategy.
* Leads identification of regional specific elements of submissions.
* Monitors and communicates key strategic issues related to program progress and issues to/from countries and HQ.
* Helps ensure HA deficiency letters are appropriately addressed in a timely manner, by providing specific input from the regional perspective.
* Triages questions and to responds to those asking about location of certain information in the dossier and forward those to HQ which require subject matter expertise.
* Ensures alignment of strategy and priorities for portfolio of products with stakeholders, e.g. GHH, MMD.
* Contributes to development and execution of regional regulatory policy issues.

Qualifications
* M.D., Ph.D., Pharm.D. with at least 5 years, or Master's degree in biological science, chemistry or related discipline required.
* At least 10 years experience in regulatory affairs is required.
* Individuals with other credentials and who possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered.
* Outstanding, interpersonal, written and oral communication skills.
* Ooutstanding collaborative skills with an ability to work both proactively and reactively in a timely manner in a dynamic fast-paced environment.
* Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities.
* Aable to manage complex problems/projects by exercising independent decision making and analytical thinking skills.
* Solid knowledge/experience of regulations, registration guidelines and regulatory processes for NCEs and product life cycle maintenance in general and preferably in APAC.
* Ability to work independently to achieve results
* Aability to work in cross-functional and international environment.
* Detail- and goal-oriented, quality conscientious, and customer-focused; ability to adhere to strict project timelines.
* Strong team player
* Good judgment and problem solving skills, with ability to identify, analyze, and resolve problems in a timely manner.
* Fluent written and spoken English is required.

If you are interested in discussing further on the opportunity in a confidential manner, or other Regulatory Affairs opportunities in the 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.76172.3273@sthreesg.aplitrak.com