Regulatory Affairs Associate Hyper Recruitment Solutions are currently looking for a Regulatory Affairs Associate to join a leading Biopharmaceutical company based in the West Sus... View Job
Regulatory Affairs Officer Hyper Recruitment Solutions are currently looking for a Regulatory Affairs Officer to join a leading Biopharmaceutical company based in the West Susse... View Job
Regulatory Affairs Manager - EU An exciting opportunity for an experienced Regulatory Affairs Manager in EU Strategy has become available within a leading Global Pharmaceutical compa... View Job
We are currently looking for a talented Regulatory Affairs professional to join the EU Regulatory team within a Global Pharmaceutical company as their Associate Director of Regulatory Affairs. As the Associate Director - Regulatory Affairs you will be responsible for defining regulatory submission strategy to ensure the successful commercialisation of products to EU markets. You will also be accountable for product maintenance and the life cycle management of CP, DCP and MRP regulated products and will lead the development of global strategy.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Associate Director - Regulatory Affairs will be varied however the key duties and responsibilities are as follows:
1. Lead the input into European Regulatory Strategy through attending Global Regulatory meetings to ensure drug development plans comply with EU guidelines and Global strategy.
2. You will support and supervise drug development strategy through defining options for Clinical Trials, Scientific Advise, briefing packages and co-ordination of agency meetings.
3. Define EU filing strategy for CP, MRP and DC procedures, while identifying risks and issues through gap analysis. You will drive life cycle maintenance activities and co-ordinate the review of QRD, PSUR and labelling submissions as required.
4. Ensure that strong and effective relationships with global teams and Regulatory Agencies are maintained to allow for clear understanding of requirements and effective representation of the company.
5. Ensure that staff follow and adhere to the defined strategy while advising and supervise where required.
To be successful in your application to this exciting opportunity as the Associate Director - Regulatory Affairs we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmacology etc.) ideally with additional experience in a product development function (e.g. Pharmaceutical Development, Toxicology, Clinical Trial etc.)
2. Proven industry experience in with pharmaceutical / biopharmaceutical regulations and guidelines for EU markets and procedures with a proven track record of working with CP, MRP and / or DCP.
3. A working knowledge and practical experience with Regulatory Affairs activities including product registration, life cycle maintenance, Clinical trial activity and drug development is vital to your application. You will ideally have experience working in cross functional / global teams.
Key Words: Regulatory Affairs | Associate Director | Strategy | MAA | Submissions | Registration | Life Cycle Maintenance | CP | MRP | DCP | EU | Clinical Trials | Drug Development | Scientific Advice | Leadership | Biopharmaceutical | Pharmaceutical
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.