Reference: 07462 Job Type: Contract Date Posted: 19 November 2018
Job Type: Contract
Date Posted: 19 November 2018
Senior Regulatory Affairs Manager – Uxbridge – 6 to 9 month contract
Reasons to want this role
- You'll be joining a leading global pharmaceutical company who are committed to ongoing staff development (through experience and training)
- This opportunity will see you working with senior stakeholders across EMEA to develop, execute and deliver the EU regulatory strategy for products within oncology, immunology and haematology therapeutic areas
- Core EU remit for regulatory dossier submissions with involvement in global projects
- Opportunities to mentor and lead junior members of regulatory team
Why join this company now?
- The company boasts a healthy balance sheet with zero short term debt
- Recently made two strategic acquisitions to further enhance their overall portfolio
- Strong long-term pipeline across multiple therapeutic areas
- Consistent year-over-year growth in 2018
What will some of your key responsibilities be?
- Working with the EMEA regulatory team (and core stakeholders across multiple other business areas), you will develop and contribute to the preparation of high-quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product applications, MAAs and variations), ensuring compliance with regulatory This will require excellent knowledge of CTD modules (common technical document); in particular, modules 3-5 - clinical, non-clinical and CMC (chemistry, manufacturing and controls)
- Frequently participates in interactions with the National Regulatory Health Authorities, and the European Medicinal Agency (EMA) within the EU for product related dialogue
- You will work to ensure that EU regulatory product strategy is developed in alignment with Global Regulatory Affairs and the Global Project Team
- Works to ensure that product development programs and life-cycle plans are aligned with the company strategic business model as well as global and EU regulatory requirements
What background & skills will you possess?
- A scientific degree (Bachelors or equivalent and above)
- The ability to network effectively with senior stakeholders and decision makers
- Exposure to EU Regulatory Affairs and will have recent experience of EU Centralised Procedure
- In-depth appreciation of CTD modules 1-5 but especially 3-5
- Thorough understanding of drug discovery / drug development, drug manufacturing and marketing required
- Proven experience within regulatory affairs showing consistent progressing in your regulatory affairs career to-date
You will benefit from joining a leading pharmaceutical organisation who are performing strongly. They are due launch a number of new major drugs in the coming years and their EMEA team is expanding rapidly. Whilst working as a contractor (6-9 month minimum duration), they will treat you very much as an essential resource to the business alongside their permanent team.
Apply today for an informal conversation to discuss your career path and how our client could progress you forward in the direction you want to take.
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.
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*Terms and conditions apply
£20.00 to £22.00 per hour
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