Regulatory Affairs Manager - Cambridge
- Recruiter
- SRG
- Location
- Cambridge
- Salary
- Competitive
- Posted
- 13 Sep 2019
- Closes
- 05 Oct 2019
- Sectors
- Engineering, Defence
- Contract Type
- Permanent
- Hours
- Full Time
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Manager - Emerging Markets on an initial 12 month contract to be based in their offices in Cambridge.
The Role:
The Regulatory Professional under the direction of a Regional Regulatory Lead will lead compilation of CMC regulatory packages for submission and may be the lead for a program under supervision.
Key Responsibilities:
- Collect and / or create country specific documents for regulatory filings worldwide.
- Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead.
- Ensure compliance via timely submissions to regulatory agencies.
- Coordinate collection of functional documents in support of regulatory applications.
- Interface with Regulatory Operations
- As appropriate support execution of regulatory strategy.
- Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance.
Skills/Experience Required:
- Hands on experience within Regulatory Affairs.
- Preparing and submitting Emerging Market applications
- Assisting in the preparation of post authorisation submissions. For example, variation applications, RTQs for centrally authorised products, or purely national products.
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or