Regulatory Affairs Senior Manager CMC Biologics *** Windsor *** EU Pre+Post approval role

Reference: TM10486S

Expiry Date: 21-12-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory Affairs Senior Manager CMC Biologics *** Windsor*** EU Pre+Post 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 for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 or Oli Dimitrov on +44 (0)207 801 3388 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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