Skip to main content

This job has expired

Associate Manager, Regulatory Affairs

Employer
GI Group
Location
England, Hertfordshire
Salary
+ excellent benefits and bonus
Start date
26 Sep 2019
Closing date
24 Oct 2019

View more

Job Details

Associate Manager, Regulatory Affairs
Medical Devices
Herts
£49k + excellent benefits and bonus

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. 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.

Gi Group are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit https://uk.gigroup.com/privacy

Company

Gi Group is one of the world’s leading staffing solutions companies, providing specialist services for the development of the labour market. Gi Group’s specialist Pharmaceutical Division supply high quality temporary and permanent staff to Pharmaceutical and Biotechnology organisations nationwide.

Gi Group’s Pharma Team can support clients onsite or remotely from Gi Group central offices and are specialists in their field with experience within the Pharmaceutical, Biotech and CRO industry.

The Group is active in the fields of temporarypermanent and professional staffing, search and selection, executive search, outsourcing, training, outplacement and HR consultancy.

Thanks to our direct presence and strategic partnerships, we operate in more than 40 countries across Europe, APAC, the Americas and Africa.

Able to serve all kinds of clients, the Group has developed strong expertise in large and multinational organisations, for which it has implemented global solutions through specialist divisions and dedicated local and international teams.

Ranked globally as one of the largest staffing firms by Staffing Industry Analysts, the Group is also a global corporate member of the World Employment Confederation (formerly CIETT).

Company info
Website
Telephone
01707 247259
Location
Gi Group - Pharmaceutical Division
James Taylor House
St Albans Road East
Hatfield
Hertfordshire
AL10 OHE
GB

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert