Regional RA Associate, APAC

REGIONAL REGULATORY AFFAIRS ASSOCIATE

Job Summary
* Responsible for supporting registrations activities in the APAC region.
* Responsible for maintenance of regulatory systems and databases.
* Responsible for review of promotional materials and sponsored events in the region.
* Responsible for supporting and ensure the standard operational procedures are up-to-date and implemented by the countries.
* Any other department activities as assigned.

Key Responsibilities
1 Product Registration
2 Processes and Compliance
* Maintains regulatory systems and databases to support effective implementation of regulatory activities to ensure timely registrations/variations and renewals of products.
* Effective implementation of regulatory activities to ensure timely registrations of new products.
* Coordinates and implement the regulatory work processes to ensure timely registrations of new products.
* Perform, review and approval of advertising, promotional material and sponsored events according to local regulation.
* Ensure that Regulatory related standard operation procedures are up-to-date and implemented in the countries.
3. Organizational Effectiveness
* Contribute to an effective regulatory affairs organization in line with corporate, functional and local objectives.
* Develops and maintains a Performance Culture

Qualifications
* Graduate in Pharmacy studies and must be a registered Pharmacist in Singapore

Experience
* At least 3-4 working experience.
* Preferably in regulatory function in the pharmaceutical industry with good knowledge of pharmaceutical regulations in Asia Pacific region.

Essential Skills and Abilities
* Ability to work effectively and collaboratively cross functionally and with global and country regulatory colleagues.
* Ability to develop and maintain strong relationships both internally and externally
* Result oriented, ability to work in a fast paced environment
* Commitment to meet the needs of global and local stake holders.
* Meticulous and organized.
* Ability to work on several projects at the same time
* Strong interpersonal and negotiation skills to influence others without formal authority.
* Strong communication skills, both written and verbal, with supervisors, colleagues, peers and external parties.
* Good spoken and written English

If you are interested in discussing further on the opportunity in a confidential manner, or other Regulatory Affairs opportunities in the pharmaceutical and medical device 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)

Monthly Salary: SGD 4500

Application Email: JIHA.62174.3273@sthreesg.aplitrak.com