Associate Manager, Regulatory Affairs
Negotiable excellent benefits and bonus (some home working considered)
Our global medical device company is looking for a new Associate Manager in Regulatory Affairs.
The Regulatory Affairs Associate Manager will lead a team of three or more employees located in Herts/ North London. The Associate Manager will be responsible for:
* Lead teams to support regulatory processes for market access of products.
* Manage budget, if appropriate.
* May lead the development of new systems and procedures.
* Plans, conducts, and supervises assignments.
* Reviews progress and evaluate results.
* Support continuous improvement activities.
* Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
* Recruit, select, and on-board top talent.
* Develop talent within team to increase performance. Actively address performance issues on team.
* Maintain a high level of team engagement.
* Participates in advocacy activities of a technical audit/nature.
Key Responsibilities include;
coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.
Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes.
Qualifications, skills and desirable experience
BS in a science, engineering or related degree. Advanced degree preferred.
Minimum of 7 years’ experience; 3 years supervisory experience preferred. Both EU and US pre-market regulatory affairs experience preferred
For further details, please contact Rosie Carden on; 01707 247259
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.