Regulatory Affairs Senior Associate
- Interim/Contract
- Regulatory Affairs, Operations
This vacancy has now expired. Please see similar roles below...
Hobson Prior are looking for a Regulatory Affairs Senior Associate to join a top pharmaceutical organisation who are focused on delivering innovations that transform patients lives. This position will be responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorizations for products and communication of general regulatory requirements.
Job Responsibilities:
- Accumulate and submit in a timely manner, regulatory documents according to regulatory requirements.
- Prepare review and approve labeling and SOP's. Assist lower level team members on complex issues.
- Deliver regulatory advice to project teams.
- Provide guidance and coaching for areas of responsibility to lower level team members.
- Respond to regulatory authorities' questions with strict deadlines.
- Maintain regulatory files in a format consistent with requirements.
- Develop and initiate complex regulatory project plans.
- Manage regulatory activities relating to specific portfolio of products/projects (product owner).
- Maintain and update existing regulatory authorizations.
- Lead or represent Regulatory Affairs in project teams.
- May review promotional material for compliance with local regulations.
- Use of critical systems such as BPLM, BaxEdge, Trackwise.
Key Skills:
- Scientific knowledge.
- Written and verbal communication skills.
- Knowledge of regulations.
- Strong negotiation skills.
Requirements:
- Bachelor's degree or country equivalent in pharmacy or related scientific discipline.
- Higher degree/PhD will be an advantage.
- Number of years of experience: A minimum of 5 years.
- Field of expertise: Regulatory or equivalent experience within a pharmaceutical company CRO, or similar organization.
- Previous experience in dealing with Belgian authorities is required.
- Previous experience in dealing with Netherlands authorities is a plus.
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.
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