Regulatory Affairs Manager

Hobson Prior are looking for a Regulatory Affairs Manager to join a clinical-stage biotechnology company on a permanent basis in Stevenage. You will participate in the development and implementation of regulatory strategy for specific programmes.

Job Responsibilities:

• Support the Global Regulatory Companion Diagnostics (CDx) Lead to implement a successful co-development strategy that bridges across the assigned gene therapies and companion diagnostics.
• You will support global regulatory sub-team and product development teams in all aspects of regulatory affairs, both strategic and operational, and provide input into relevant sections of development plans for assigned programmes.
• Ensuring preparation and submission of high-quality regulatory documents.
• Represent as the contact point for internal and external clients, including CROs and regulatory authority interactions.
• Accountable for the regulatory project management for assigned projects i.e. planning and tracking submission and approval timelines, regulatory commitments, etc.
• Contribute to the growth of the Function, including supporting GxP compliance and inspections and regulatory systems.
• Remain expert and up to date on global regulatory requirements including nonclinical and clinical aspects.
• Keep up-to-date of relevant regulatory intelligence and ensuring this is communicated, appropriately, across the Company.
• Assist with training of staff in regulatory matters as required.

Key Skills:

• Strong influencing and interpersonal skills including strong oral and excellent written communication skills.
• Highly computer literate.
• Ability to work effectively and collaboratively in a matrix environment across different personalities/cultures and functions.

Requirements:

• Relevant degree in a life science / science discipline.
• A minimum of 6-8 years' experience in regulatory affairs across various companies preferably in biotechnology/biologicals and/or rare diseases in a centralized European setting where US experience would be a bonus.
• Knowledge and understanding of EU and ICH guidelines and experience of working to GxP is essential.
• Experience in the preparation of regulatory submissions during the lifecycle particularly INDs/CTAs, scientific advice briefing documents, PIPs and/or orphan designation applications or sections of the MAAs/NDAs and/or post-approval submissions.
• Interactions with the EMA and European national regulatory authorities required (any experience with FDA interactions would be a bonus).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.