An outstanding opportunity for a Senior Regulatory Affairs Professional to join a well established Regulatory Consultancy Company and play an instrumental role in the growth of the business.
Duties will include:
- management of product licence registration and post registration activities with the appropriate regulatory authorities on a global basis
- preparation of any regulatory dossiers and/or supporting documentation
- supporting clients with the appropriate documentation to facilitate registration/maintenance of products
- providing leadership and guidance to junior stuff and ensuring site activities comply with regulatory requirements.
- reviewing and interpreting regulatory guidelines.
- Providing in house training on regulatory topics as required
- Supporting marketing and business development activities. This may include (but not be limited to):
– advising on regulatory activities, timelines and costs for new business proposals as required
– participating in new business meetings, kick off meetings and project meetings as required.
The candidate should be qualified in Life Sciences and have broad experience in pharma regulatory environments for US/EU markets. Sound knowledge of Global Regulatory Procedures, including marketing applications, negotiation and product licensing knowledge, proven success in agency influencing and negotiation are essential. Broad level of experience within the Pharmaceutical industry with knowledge of Regulatory Affairs and knowledge of product development is a must.
If you feel you have the relevant skills and experience for this role please send your application to firstname.lastname@example.org. Please quote reference S_RAPM in all correspondence.