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Regulatory Affairs Senior Manager CMC Biologics Windsor EU PrePost approval role
Overview
Regulatory Affairs Senior Manager CMC Biologics Windsor EU PrePost approval role Take the Regulatory lead for a number of Biologics including monoclonal antibodies for a very highly rated Biopharmaceutical company that hires and retains the best. We have a great new role with a dynamic and expansive medium sized Global biotechnology company where you will take the Regulatory lead for a number of Biologics including monoclonal antibodies for EU, International & Emerging Markets for both Pre and post approval activities. You will act as the Regulatory CMC liaison and CMC expert for your projects, reviewing and building submissions, developing effective proactive CMC strategies for new products and for lifecycle regimes in EU, International and Emerging Markets. This is an excellent time to join this growing organisation. They have an excellent reputation within the industry and have a number of high profile regulatory professionals who are responsible for setting high standards. In return they are seeking professionals who can show leadership, high level influencing and persuading with an excellent cross-cultural awareness and understanding of the regulatory framework. Ideally you will be a collaborative team player with excellent planning, organizational and project management skills who is proactive and flexible in your attitude and approach and must be able to demonstrate strategic thinking and decision making and show excellent communication, interpersonal and relationship building skills. Role / Description: Acts as the lead Regulatory CMC expert for review and finalising regulatory strategy documents and building submissions. Develops effective proactive CMC strategies for new products and for lifecycle in Europe. Manages CMC aspects of projects/products, including major, complex applications submitted to regulatory agencies in Europe. Ensures that CMC regulatory submissions are complete and comply with applicable internal standards and regulatory requirements. Works across multiple functional and project teams as team leader and/or member; Serves as technical counsel to senior leadership. Trains and mentors other team members. Salary and Package: This role is positioned at Senior Manager level with a strong expectation that you will succeed to become an Associate Director and potentially move into a global regulatory role. The package includes an exceptional salary, high level bonus, lucrative LTI scheme, company car and petrol card or car allowance, flexible healthcare package (including, dental, healthcare & life insurance), exceptional pension contribution from the company and real flexible working options including home working 2-3 days a week. 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.