Regulatory Senior Manager CMC

Proclinical is advertising a vacancy for a Regulatory Senior Manager CMC position with a leading global pharmaceutical company that focuses on developing first-in-class therapeutics that provide meaningful advances to patients who live with rare genetic diseases. Based in London, this is an exciting opportunity to work with a company that aims to make meaningful impacts on patients' lives.

The Regulatory Affairs Senior Manager will work with US based-project teams and subject matter experts to support the clinical development and life cycle management of biological protein medicinal products in the EU and Switzerland. They will work closely with in-house CMC teams, partners, contract research organisations, and global health authorities to ensure rapid review and approval of the CMC portions of clinical trial applications, post approval applications, or other CMC-oriented filings.

Job Responsibilities:

• Providing EU Strategic input on CMC expectations for product development in early and late phase clinical trials.
• Providing EU Strategic input on CMC expectations for post approval variations.
• Collaborating with internal and external partners to provide high quality submission in line with Company objectives and timelines.
• Assessing manufacturing changes within the Phase I-III and post approval environments.
• Planning and executing submissions and responses to questions.
• Interacting with subject matter experts as required.
• Managing and communicating review outcomes to impacted stakeholders.
• Representing the EU Reg CMC team on process enhancement initiatives.

Skills and Requirements:

• A B.Sc. or higher degree in life sciences, such as biology, chemistry, molecular biology, or similar.
• Strong knowledge of the manufacturing of biological medicinal products with proven relevant EU CMC Regulatory Affairs experience.
• Particular experience is required in:
  • Extensive knowledge and experience of EU CMC Reg Affairs guidelines and regulation relevant to biological medicinal products.
  • Change control assessment.
  • IMPD authoring.
  • Variation/lifecycle submission authoring, reviewing and management.
  • Interaction with EMA or other Regulatory Authorities.
• 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 Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.Proclinical.com.

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.

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