Regulatory Affairs Executive (Up to $4,500)
GMP RECRUITMENT SERVICES (S) PTE LTD| Date Posted: 25-Apr-2021
EA Licence No: 09C3051|EA Personal Registration No: R1654652
Bachelor's / Honours
- Maintain comprehensive understanding and updated knowledge of the regional and international regulations and standards applicable to the company products and upkeep the relevant regulatory databases
- Implement regulatory-related policies and standard procedures that are in accordance with applicable regulations and standards
- Collaborate and maintain good relationships with external customers (including regulatory agencies, certification bodies, service providers, distributors, etc.)
- Provide regulatory advice, develop, and maintain links to other teams (including quality, production, HQ’s regulatory affairs) so that appropriate development and quality plans may be established
- Responsible for obtaining certification and compliance of the manufacturing site (eg. ISO22716, GMP, Halal, etc.) on a timely basis
- Maintain business licenses and other authorities’ licenses for business operation
- Assess the impact of regulatory changes on the company; monitor, perform gap analysis and ensure timely and appropriate reactions to regulatory changes
- Assist in the implementation of optimal regulatory strategies to ensure regulatory and commercial success in the most effective and timely manner
- To provide regulatory collaboration or undertake specific tasks in the project initiatives with cross-functional teams on technology transfer, CMC (Chemistry and Manufacturing Control), or other datasets for timely compilation
- Responsible for tracking and supporting departmental QMS and related SOP, periodic reports, surveillance of new regulatory changes, etc.
- Minimum Degree in Science, preferably in Chemistry / Biochemistry / Biomedical Science / Cosmetic Science or similar
- 3 years of experience with the regulatory environment and in the Cosmetic, Health Food, Dietary Supplement, Pharmaceutical or other FMCG industry
- Good understanding of global regulation – ACD, USFDA, TGA, EMA, ISO22716, PICs GMP, Halal, etc
- Technical skills to guide cross functional teams on development requirements from a regulatory perspective.
- 5 days' work week, Monday to Friday, 9am to 6pm
- Must be comfortable to work in Tuas area from August 2021 onwards
Please note that only shortlisted candidate will be notified.
GMP Recruitment Services (S) Pte Ltd | EA Licence: 09C3051 | EA Personnel: Jlynn Oh| Registration No: R1654652
GMP RECRUITMENT SERVICES (S) PTE LTD