Our Client is a US MNC and a pioneering leader in the Pharmaceutical industry. They are currently seeking experienced and motivated professionals to join their Regulatory affairs Team in Singapore.
Senior Regulatory Affairs Specialist (1-year contract)
Reports to Regulatory Affairs Manager
- Contribute to the planning and execution of registration strategies for medicinal products and medical devices in Singapore and Brunei to ensure timely and successful registration outcome
- Assist with variation submissions and follow through with Regulatory Agency until approval.
- Create artworks for variation submission and commercialization post Regulatory Agency approval in accordance with Singapore and Brunei regulations and internal procedures.
- Provide guidance to GHH and other functional groups to ensure local compliance with registration requirements as well as legal requirements administered by the Health Sciences Authority e.g. Health Products Act, the Medicines Act, the Poisons Act, Medicines (Advertisement and Sale) Act etc.
- Maintain and update internal regulatory affairs databases and systems
- Support regulatory team with other administrative tasks.
- Manage document archival.
- Graduate degree in Biological/Chemical Sciences/Pharmacy, Singapore-registered pharmacist will be ideal.
- At least 5 years of relevant commercial pharmaceutical regulatory affairs experience and knowledge and the ability to work cross-functionally and independently to drive results. A good team player with excellent communication skills and good working attitude.
- Detail-oriented, meticulous and organized
- Able to work within targeted timelines
- Good project management skills
- Good communication and interpersonal skills.
Location: Bouna Vista
Salary up to S$5500per month
Interested applicants, please submit resume to; firstname.lastname@example.org (R1110894)
Consultant Name: Yap Yen Leng
Licence no: 02C3423
Yen Leng Yap EA License No. 02C3423 Personnel Registration No. R1110894