Global Regulatory Lead - Biosimilars

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. United Kingdom
Cambridge, Cambridgeshire
Posting date: 01 Aug 2019

A global pharmaceutical company is advertising an exciting new job opportunity for a Global Regulatory Lead - Biosimilars to join their office in Cambridge. This is an excellent opportunity to join an innovative company that operates across 160 countries.

Job Responsibilities:

  • Develop and lead regulatory strategies and drive the execution of registration plans for development and regulatory approval of new biosimilar assets, and ongoing compliance of marketed products, working closely with other biosimilar focused technical functions across the organisation.
  • Provide regulatory advice and expertise to R&D, commercial asset teams, business development, alliance partners and other activities related to developing and maintaining the company's biosimilar pipeline.
  • Provide regulatory expertise for the biosimilar asset portfolio, utilising optimised regulatory pathways and submissions to achieve expedited and commercially competitive approvals of biosimilars.
  • Define regulatory pathways and strategic options for biosimilar expansion globally, ensuring alignment with the Independent associated Companies (IACs) business cases and commercial planning.
  • Maintain ownership and accountability for timely and effective Regulatory Agency negotiations and interactions throughout the internal biosimilar asset development, registration, and maintenance process.
  • Responsible for regulatory representation in Alliance Management with Partner Companies for their assigned biosimilar assets.
  • Provide strategic direction and oversight of delivery output from outsourcing partners to ensure alignment with regulatory strategies, effective execution, and quality submissions and regulatory agency interactions.
  • Provide strong biosimilar regulatory expertise into assigned Due Diligence for new assets.

Skills and Requirements:

  • Extensive regulatory experience in development and registration of biosimilars globally.
  • A track record of overseeing a substantial number and quality of drug development regulatory submissions and approvals, including Clinical Trial Applications (CTAs), Investigational New Drug (IND) applications, Marketing Authorisation Applications (MAAs) , and New Drug Applications (BLAs).
  • Experience working with or from within health authorities.
  • Knowledge, experience, and track record of delivering successful regulatory outcomes for biosimilar products across various territories including US, EU, and Asia.
  • Experience working with diverse Regulatory Authorities such as EMA, FDA, TGA, PMDA etc.
  • A strong strategic regulatory mind-set and demonstrated ability in leading company interactions with various regulatory health authorities across diverse issues in diplomatic and persuasive ways.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Pieter Verbeelen at +44 203 854 2628 or upload your CV on our website -

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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