Senior Regulatory Affairs Manager

ProClinical is seeking a Senior Regulatory Affairs Manager on behalf of their client, a leading global biotechnology company. The company focuses on oncology and inflammatory disease. This is a contract role based on Uxbridge, UK.

Responsibilities will include:

• Contributes to the development of EU regulatory product strategy based on Company strategic imperatives, product knowledge, global and regional regulatory requirements, including assessment and inclusion of innovative regulatory pathways to achieve regulatory approvals meeting business needs.
• Maintains awareness of emerging issues that may impact regulatory product strategy and Company EU regional business.
• Maintains knowledge of current EU regulatory guidance and procedures and reviews new guidance for impact on regulatory product strategy and discusses with management.
• May have global responsibility for specific projects which will require; a knowledge of global regulatory requirements, development and ownership of the Regulatory Development Plan (RDP), responsibility for Worldwide submission plans and accountability for global regulatory documents such as clinical trial/marketing applications and for interactions with global Health Authorities.
• Responsible for or contributes to the execution of regulatory product strategy and for achieving timely regulatory approvals with competitive product labels and the maintenance of licences for products assigned.
• Working with other functions as necessary, develops and contributes to the preparation and content of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, paediatric waiver requests, MAAs and variations), ensuring compliance with regulatory requirements. Contributes to the review of key documents before submission.
• Responsible for or participates in interactions with the European Medicinal Agency (EMA), and National Regulatory Health Authorities within the EU for product related discussions.
• Reviews draft protocols, acts as Regulatory Franchise Team representative in clinical study teams and liaises with the individuals with CTA or CRO oversight responsibility.
• Acts as Subject Matter Expert on designated studies in the event of the Health Authority Inspection
• Responsible for the delivery of Content Plans to allow publishing and timely dossier submission

Key Requirements/Knowledge:

• Bachelor's degree in scientific discipline or equivalent required.
• Experience in EU Regulatory Affairs & recent experience of EU Centralised Procedure required.
• In-depth knowledge of current EU regulatory requirements essential
• In-depth understanding of CTD modules; non-clinical, CMC, Clinical
• Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.
• Knowledge of Therapeutic area for assigned projects
• Experience of leading projects through Regulatory Procedures
• Experience in Haematology/ Oncology or Inflammation/ Immunology preferred
• Experience of contributing to Ph III protocols & able to contribute to clinical development plans.

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 Peter Duvall at p.duvall@proclinical.com 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.