Job Description
Have you a passion to be part of cutting-edge science?
Our client is a young exciting multinational biopharmaceutical company enjoying exceptional growth combined with a strong high potential pipeline. Rapid expansion has led to the need to create a management position in Regulatory Affairs. The growing need for EU-specific expertise on their development programs, as well as to keep the company compliant on emerging EU legislation and processes, has led to the need to create a new position. The role is positioned at the Associate Director level to enable independent working and leadership in direct interactions with EU Regulatory agencies and with their business partners. This role will be focused on supporting development activities and managing teams in the area of General Medicine.
Job Spec:
- Build the representation of the company's 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 company’s 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.
- A degree in a scientific discipline, an advanced degree (Masters or PhD) is preferred.
- 8+ years regulatory industry experience with a focus on supporting products through clinical development. Experience of managing and developing staff members desirable.
- 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.