- APAC coverage
- Pharma industry
- Dynamic work environment
APAC Regulatory Affairs Manager
Our client is currently in search of an APAC Regulatory Affairs Manager due to business needs.
Reporting to the Head of Regulatory Affairs, you will be responsible for assimilating knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
You will provide strategic regulatory inputs to the business for new product submissions and launches, accelerate regulatory submissions/approvals, product lifecycle maintenance and post-market compliance.
To be successful, you should possess a strong degree in Pharmacy, Biology, Chemistry, Pharmacology, or related subject and at least 5 years regional regulatory (preferably APAC) experience. You should possess strong knowledge of regulatory processes and requirements for new submissions, MA maintenance and variation submissions.
Suitable applicants should be proficient in CTD/ACTD requirements.
Project Management experience is a strong plus (not a must-have).
Suitable applicants may write in to Maggie@Talentreq.com with resume for more in-depth discussion.
EA Licence: 17S8795 | EAP: R1105973