Regulatory Affairs Manager
- Employer
- Barrington James
- Location
- Netherlands
- Salary
- Up to €100,000
- Start date
- 9 Feb 2021
- Closing date
- 11 Mar 2021
View more
- Discipline
- Regulatory Affairs, Project Management, Regulatory Project Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
The company
My client are a full service consultancy who support Top 10 Pharma's & innovative Biotech's globally. Working at this company is like being in an entrepreneurial start-up with the financial backing of a top consulting firm. You are are given the opportunity to stretch & learn on your own terms.
Purpose of the role
- Responsible for local regulatory activities for The Netherlands, supporting a portfolio of products (i.e., as Member State)
- Responsible for supporting central regulatory activities for a portfolio of products registered via the Centralized Procedure (i.e., as EU/EMA contact)
Key responsibilities
- Tracking and updating regulatory management systems and databases on a regular basis
- Review and confirmation of submission strategy, including submission documentation requirements
- Coordination with Central Regulatory Team for submission packages for variations, renewals, new product applications, PSURs, etc.
- High level review of submission packages and preparation of country specific module 1 documents in English or Dutch language (as applicable)
- Correspondence with respective Health Authorities regarding submission timelines, approvals, and responses to Health Authority queries
- Act as a local regulatory affairs point of contact for regulatory queries from internal functions (e.g., Marketing, QA, Supply Chain, etc.)
- Support regulatory planning process by providing local regulatory input to annual planning program
- Distribution of Health Authority communications within the company
- Coordination with Central Regulatory Affairs and other functions for certificates and samples for submission to Health Authorities
- Review / approval of labelling, artwork changes, promotional material, abbreviated product information and addenda to Clinical Overviews
- Translation activities related to labelling, artwork and other regulatory documentation as required
- Support compliance activities (e.g., change control)
- Ensure changes to local regulatory requirements are communicated effectively and relevant actions taken to ensure continued compliance of marketed products
- Maintenance of products registered via the EU Centralized Procedure
- Communication and coordination with regulatory colleagues in multiple Member States, suppliers and other third parties (e.g., translation partner, contract manufacturers, etc.)
- Provide input on regulatory risk assessments
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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