Associate Liaison Regulatory Affairs
- Interim/Contract
- Regulatory Affairs, Operations
This vacancy has now expired. Please see similar roles below...
Hobson Prior currently have an opportunity for an Associate Liaison Regulatory Affairs to support Regulatory Affairs activities in the EU region, the non-EU CES countries and Switzerland. You will join a leading global biopharmaceutical company that has been inventing for life for more than a century.
Job Responsibilities:
- Provide strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements.
- Communicating with Regional Submission Planner (accountable for planning in Regulatory Operations) to provide input and ensure alignment on submission plans.
- Collaborating closely with Regulatory Operations to establish submission timelines of Module 1 components.
- Ensuring updates to regulatory databases.
- Drafting and organizing the gathering of the module 1 components.
- Working closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies.
- Preparing the English Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Worldwide Product Labelling.
- For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA.
- Keep up to date with EU procedural requirements and legislation.
Key Skills:
- Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
- Ability to act as intermediary across boundaries.
- Capable to evaluate new ideas and proposed methods for practicality and ease of implementation.
- Ability to review regulatory documents for accuracy.
Requirements:
- Degree in life sciences.
- A minimum of 2 years' experience in the pharmaceutical industry.
- Knowledge of EU regulatory procedures and development of medicinal products in general is preferred.
- Understands the end-to-end pharmaceutical lifecycle.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Similar jobs
£90000 - £100000 per annum
Witney, England
Hobson Prior is collaborating with a fantastic pharmaceutical organisation who are seeking for an individual to join their team on a permanent basis.
£55000 - £65000 per annum
Hertfordshire, England
Hobson Prior are currently looking for a Regulatory Affairs Manager to join a fantastic pharmaceutical organisation on a permanent basis located in Hertfordshire.
Can’t find what you’re looking for?
We don’t advertise all of our vacancies online. Register with us and we can let you know the next time your perfect role becomes available, or want to discuss your options with a specialist?
Register