Regulatory Affairs Associate Director

Hobson prior have an exciting opportunity for a Regulatory Affairs Associate Director to join a multinational biopharmaceutical company. Within this role you will be focused on supporting development activities and managing teams in the area of General Medicine.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Build the representation of the EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
• Collaborate with Development teams in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
• Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.
• Execute clinical trial applications for assigned programs and provide leadership for team members responsible.
• As needed, support activity with Business Partners to ensure the EU regulatory strategy meets the business objective.
• Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
• Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
• Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.
• Lead, manage and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams where required.

Requirements:

• Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
• Experience of providing EU regulatory strategy for rare diseases is desirable.
• Experience of moncloclonal antibodies, gene therapies, siRNA is desirable.
• Experience of bringing a product through EU approval is a distinct advantage.
• Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
• Ability to negotiate and concisely express clear positions to stakeholders at all levels.
• Experience of directly working with national regulatory agencies and leading agency meetings face to face.
• Excellent written and verbal communication skills.

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.