- Our Client is a well-established Firm, dealing with Health supplement products.
- 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 (e.g. 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 or Chemistry/Biochemistry/Biomedical Science/Cosmetic Science.
- 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.
- Working Location: Tai Seng (Company will shift Tuas in September 2021).
- Working Hours: Mondays to Fridays, 9am to 6pm.
- Critical: Due to the organization's affirmed support and commitment to developing a Singaporean core, this role is only available to Singaporeans.
To apply, please visit www.gmprecruit.com and search for Job Reference: 18174.
To learn more about this opportunity, please contact Novita Tan at email@example.com
We regret that only shortlisted candidates will be notified.
GMP Recruitment Services (S) Pte Ltd | EA License: 09C3051 | EA Personnel: Novita Tan | Registration No: R1220374