Description
Senior Manager Regulatory Affairs - Global PharmaLocation: London
Salary: £65,000 - £75,000 circa + Car allowance and excellent package
Role:
This opportunity is with an excellent Global Pharma who are rapidly expanding. You will be leading a team of Regulatory Managers focusing on:
- Plan, manage and execute established product activities including new registrations and life cycle management for defined products globally (e.g. renewals, variations, safety updates, Authority commitments and ensuring compliance with regulatory requirements)
- Act as the lead regulatory representative in relevant meetings including e.g. Brand Team or Global Regulatory Oversight Committee, providing strategic input, product risk/benefit analysis and market intelligence, in addition to operational support to ensure timely submissions and approvals
- Acting as Global Regulatory Lead for assigned globally approved product(s) and being responsible for having global oversight as well as planning, coordinating and managing all regulatory activities in a timely manner
- Act as point of contact and leverage effective relations with EU Authorities where required and to drive submissions through CP/MRP/DCP in line with regulatory requirements
- Provide product knowledge, regulatory expertise and strategic advice whilst acting as lead representative in internal cross functional meetings. Review documentation for accuracy, consistency and alignment with regulatory market requirements and to ensure quality submissions, reduced questions and timely approvals
- Provide input as required on protocol, CTA, DSUR for phase IV clinical trials
If you are keen to find out more information contact our Senior Regulatory Consultant Natalie Hopkins on to be shorlisted. Interview will be happening ASAP so make sure your C.V has been sent to n.hopkins(a)realstaffing.com to apply.
Real Staffing have a Regulatory team of 7 consultants focusing purely on Regulatory roles across all levels. If this role is not right for you but you would like to know about other roles give Natalie Hopkins a call on for an informal call.
To find out more about Real please visit www.realstaffing.com