Product Features
Blog
Contact Us
Sign In
Advanced Regulatory
,
London, Greater London
Regulatory Affairs Senior Manager CMC, Early Dev. Clinical Lead (Gene Therapy), M4 Corridor
Overview
Regulatory Affairs Senior Manager CMC, Early Dev. Clinical Lead ( Gene Therapy) , M4 Corridor This is a role for those who enjoy early development projects and have good experience in IND/IMPD/CTA regulatory submissions for biotech or small molecule products We have a rare, unique and interesting role for one of the world’s most successful, dynamic and innovative biotechnology companies. You will be working on early stage programmes (PI & PII) for a variety of different indications including biologics, small molecules and gene therapy projects across 2 major therapy areas. This role is responsible for providing regulatory CMC expertise into the development and implementation of the regulatory strategies, operations and planning for the CMC aspects of assigned early development programs as the regional or global Regulatory CMC Clinical lead. What’s great about this role is not only the variety of indications that you can work on (biologics, small molecules and gene therapy projects), but you will have the scope and option to take an indication forward through the development lifecycle to MAA/BLA as well as gain vital US project exposure, which will always enhance your career further down the line. The position is graded senior manager grade and comes with an industry high basic salary, car allowance, yearly bonus (around 20%), lucrative yearly stock plan with a low vesting period and a comprehensive health and benefits plan including a high company pension contribution. Duties and Responsibilities: Provide EU and US strategic and operational regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives. Preparation and delivery of CMC regulatory plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (IND/IMPD/CTAs) Responsible for regional submission from defining and agreeing content with CMC global regulatory lead to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities in assigned regions. Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions Managing CMC aspects of routine and non-routine regional Health Authority interactions including issue resolution and negotiation of approvals, as delegated. Monitoring changes in the regulatory CMC environment in assigned regions to support and advise CMC global lead and teams. Qualifications: At least 5 years of experience in Regulatory CMC with knowledge of IND/IMPD/CTAs Successful authoring and contribution to delivering CMC submission documents of development products (biological and/or chemical entities) Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products. To Apply To apply , please send a full CV to TheoAdvTalent.com , or alternatively, contact Theo Moore on 44 (0)207 801 3384 or Oli Dimitrov on 44 (0)207 801 3388 . We are assigned these roles by our client and will provide you with support throughout the hiring process. About Advanced Search & Our Network Advanced Search , has a network of affiliated companies including ADV Regulatory , and ADV Talent Partners . Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005. Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels. Contact us today to see how we can help you make that next career move on 44 (0)207 801 3380 All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.