Regulatory Affairs Manager
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|Area||Greater London, UK|
|Sector||Pharma / Biotech|
|Salary||£ 55,000 ~ 70,000 Annual Rate|
- Linkfield are currently partnering with a small Pharmaceutical company who are looking to grow their Regulatory Affairs team. As part of their growth plan, they have an exciting opportunity for a Regulatory Manager to work alongside the senior management team on a daily basis, in a supportive and progressive environment. The chosen candidate will have the opportunity to make a real impact to the company.
- The Role:
- Responsibilities will involve:
- · Planning, preparation and submission of MA applications, post approval, variations, renewals, post marketing commitment submissions and other ad hoc activities in support of maintaining MAs in the EU, MENA, Africa, Asia and the UK.
- · Working alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines and conditions in these markets.
- · Reviewing and submitting artwork and labelling changes, including management of third party artwork house.
- · Bachelor’s degree equivalent or higher qualification within life science
- · Authoring & preparation of regulatory packages and documents for submissions
- · Positive can-do attitude
- · Knowledge of EU, Asia and MENA regulations and post approval procedures
- · Conducting gap analysis and review of dossiers
- · Creating and authoring SOPs
- · Opportunities for progression and development as the company grows
- · Company mobile and laptop
- · Contributory pension scheme
- · Support and cooperation from a close-knit team in modern offices
- · 31 days’ holiday including statutory holidays, plus birthday
- · Company healthcare scheme
- Location: Hertfordshire
- Role type: Permanent Position
- For more information please get in touch with Natalie Jones on 0208 183 5059 or email firstname.lastname@example.org