Regulatory Affairs Manager

Regulatory Affairs CMC Manager
Location: Dublin (Relocation support offered)
Salary: Up to 80,000 per annum
Permanent position
Job reference: JO-2004-449510

Regulatory Professionals are collaborating with an expanding pharmaceutical organisation specialized in rare diseases, orphan drugs and Cell & Gene therapies. In this position you will plan, author and manage the assembly and timely submission of CMC related sections of IMPDs, INDs, NDAs, MAAs, post approval, renewal, line extensions and other dossiers to meet filing requirements. Further duties include;

- Developing and implementing strategies for the earliest possible approvals of regulatory submissions.
- CMC regulatory strategies
- Providing expertise on CMC regulatory matters
- Maintaining current regulatory knowledge and awareness of new scientific or manufacturing technology and advise management of significant developments

Requirements
- Must have a relevant life sciences degree
- Experience and knowledge in preparation of CMC sections of IMPD, IND, MAA, NDA
- Working knowledge of EMA, FDA and ICH regulatory guidance and regulations.
- 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
- Experience with biological products would be advantageous.

If you would like to apply for this position or discuss our other active positions please contact Charlie on 01189 522 797 or [email protected].
If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*