Regulatory Affairs Senior Manager

Proclinical is seeking a dedicated and experienced professional for the role of Regulatory Affairs Senior Manager. The successful candidate will be responsible for providing regulatory support for one or more products, evolving and executing regional regulatory strategies, and managing effective agency interactions. This role is crucial in progressing our pipeline through timely regulatory approvals and ensuring regulatory compliance.

Responsibilities:

• Define and advise the Global Regulatory Team on regional considerations in developing regulatory strategy.
• Ensure European regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• Develop and implement regulatory strategy and executional plans, and manage regulatory submissions for assigned products.
• Lead development of regional regulatory documents and meetings, and provide regulatory advice on regional requirements.
• Coordinate and provide guidance to company responses to requests from regulatory authorities.
• Communicate and ensure alignment with proposed regulatory strategies, characterizing and understanding expectations, regulatory risks, and mitigations.
• Estimate the likelihood of regulatory success and timelines based on proposed strategies and communicate to stakeholders.
• Maintain awareness of new and developing legislation, regulatory policy and technical Regulatory guidance, and evaluate and communicate impact.
• Act as contact and create relationships with agency staff on specific product assignment.

Key Skills and Requirements:

• Demonstrable experience acting as therapeutic area European Regulatory Affairs lead.
• Practical Regulatory knowledge of regional legislation.
• Experience with national legislation and regional regulations relating to medicinal products.
• Understanding of the regional regulatory procedures for Clinical Trial Applications, Marketing Authorizations, post approval changes, extensions, and renewals.
• Understanding of drug development.
• Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage.
• Comprehensive understanding of regulatory activities and how they affect projects and processes.
• Experience of working directly with the EMA and Centralised Procedure is preferred.
• It is preferred to have experience in Inflammation, Cardiovascular or Bone as a therapeutic area.
• Experience working with biotechnology products is preferred.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

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.