This is an exciting opportunity for a Regulatory affairs Associate to join a rapidly expanding team. The global regulatory affairs team are responsible for handling regulatory submissions to competent authorities around the world.
As Regulatory Affairs Associate, you will have had previous experience working within R&D in the pharmaceutical industry as well as practical experience working within Regulatory affairs ideally as part of the submissions team.
USPs of this Regulatory Affairs Associate position include:
- The company you will be joining will empower you with as much responsibility as you need in order to develop your skills and expertise
- You will be developed in a fast track environment
- If you have some experience of regulatory affairs but have some areas that require further training you will receive this
- It is a fast paced place to work ensuring that there is never a dull moment
- Aligned to a Brand team you will have lots of responsibility and ownership for your product / therapy area from a regulatory perspective
Your key roles and responsibilities as Regulatory Affairs Associate will include the following:
- To develop and implement regulatory strategy for the assigned product Category.
- To achieve marketing authorisations for products in key global markets.
- To be the central point for submissions in key global markets.
- To lead projects to gain authorisations in key global markets.
- Keep on top of the ever changing Legislative environment and ensure that all relevant parties are kept up to date with the changing legislative scene.
- Assist in the preparation of documentation in a way that regulatory authorities are likely to accept and deal with constant changes which require regulatory action.
- Meeting business / project deadlines in a busy environment.
- Building relationships with regulatory personnel around the World.
- Able to respond to last minute requests.
- To be able to manage expectations and suggest workable alternatives.
For more information, or to apply for this Regulatory Affairs Associate job, please contact Jonathan Hart-Smith on 01438 743 047 or email firstname.lastname@example.org.
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