Expiry Date: 28-11-2021
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Regulatory Affairs Associate Director Global CMC – EU, US, AsiaPac & LatAm – Based in the M4 Corridor
Due to further planned expansion my client is seeking an Associate Director Regulatory CMC GRL to lead a number of an exciting development projects!
My client is a global SME pharmaceutical company with a strong development pipeline and a number of Blockbuster marketed products. Although considered medium in size, their spending on R&D make them competitive at the highest level and sales have continued to rise and rise year on year. With 10 major product launches planned over the next 3-4 years they are hitting impressive levels of growth and achievement.
For Regulatory Affairs CMC professionals, they offer real Global leadership roles from levels from their head office based in the South-East/M4 Corridor and have gained a great reputation for giving regulatory professionals real career progression including direct people management.
This role is focused on taking the lead for strategic development activities initially in the EU and US and then all major international regions and territories for a combination product in Phase 3, with the global NDA/MAA planned for 2022. You will be leading and co-ordinating CMC regulatory and related change control activities for these projects and matrix leading EU and US RA CMC liaisons on Regulatory Sub Teams, Global CMC Development Teams and Regulatory/QA liaison team for future global submissions, advising on Regulatory CMC issues. The US offices are also on the East Coast, and with the Global HQ in Europe there are no late-evening US calls.
Ideally you will offer extensive CMC regulatory project management and leadership experience, having working closely with manufacturing sites, R&D and regional regulatory colleagues, with an enthusiastic, positive, and proactive approach, with a determination to succeed. You will have at least 10 years in Regulatory Affairs CMC and have experience of European & International CMC regulatory submissions, requirements and procedures.
The package on offer is excellent and includes a full and comprehensive benefits package with full medical coverage for you and your family. The salary, bonus and car allowance are very competitive and you will receive a yearly stock options package. There is great flexibility around home working and time spent in the office, which offers a very nice work-life balance.
Based in the M4 Corridor, my client is easily commutable from Slough, High Wycombe, West London and Oxford. Parking is available. Currently the role is 100% home based!
For compelling candidates a relocation package is available.
To apply for this role, please hit the Apply button or contact Theo Moore on toll free +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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