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Regulatory Affairs Manager, Singapore

2 weeks ago

Singapore DN & ASSOCIATES EXECUTIVE SEARCH PTE. LTD. Full time

Our client is a long-standing player in the healthcare sector, specializing in the distribution and promotion of pharmaceuticals, medical technologies, and wellness-related consumer goods across key regional markets. With a strong track record, they are widely regarded as a reliable and committed provider of health-related solutions. Guided by a forward-looking vision, they aim to focus on addressing the evolving needs of patients, working to improve health outcomes by ensuring access to advanced and innovative medical offerings through their robust network of global collaborations.

The Regulatory Affairs Manager, Singapore will be responsible for:

- Managing and ensuring timely regulatory submissions for new products, indications, renewals and variations.
- Responsible Person for Importer’s Licences, Wholesaler’s Licences, Assembly Licences with HSA (Therapeutic Product/Medical Device).
- Acting as the Management Representative of the company, ensure compliance with HSA requirements for Good Distribution Practice (GDP) and Good Distribution Practice for Medical Devices in Singapore (GDPMDS).
- Liaise with key stakeholders, including regulatory authority, principals, healthcare providers and industry
- Maintain the Quality and Pharmacovigilance system
- Team Lead for internal and external audits by authorities and suppliers
- Review and approval of advertising and promotional materials
- Review and ensure compliance with principals’ Quality Agreement
- Support sales and marketing, tenders and business development in regulatory related areas
- Degree in Pharmacy, registered with the Singapore Pharmacy Board
- Knowledgeable on Singapore regulatory landscape and Good Distribution Practice
- Strong team player who is willing to learn and possess a high level of initiative
- Prior experience in coaching and guiding junior team members
- Meticulous, well-organized and able to meet deadlines
- Excellent written and verbal communication skills
- Proficient in MS Office

EA: 11C3242

R1108969