Global Regulatory Affairs Lead

Hobson Prior are currently in search for a Global Regulatory Affairs Lead to join a fantastic biopharmaceutical industry on a permanent basis located in Basel. Our client is focused on providing access to innovative treatments.

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

Key Responsibilities:

• Be the single point of contact/single point of accountability within GRA on the Core Asset Team (CTA) and Medicines Development Team (MDT) for assigned program(s).
• You will chair a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s).
• Responsible for US and EU/CH regulatory strategy & operations.
• Provide global regulatory leadership of assigned program(s).
• Develop global regulatory strategies including risk assessment and mitigation strategies and the use of expedited regulatory pathways globally to accelerate patients' access.
• Develop and coach direct reports.
• Attend major/critical regulatory Agency meetings for assigned program(s).
• Cooperate with other departments and affiliates within the company, regulatory authorities, partners and regulatory consultants.
• Participate in strategic and regulatory evaluations of in-licensing matters.
• Authority to approve services and costs within budget and delegation from the company's authorized signatories.
• Review regulatory SOPs as needed.

Key Skills:

• Excellent communication and negotiation skills.
• Highly self-motivated and able to drive activities, solution-oriented personality.
• Strong team-player with collaborative, respectful and flexible attitude and high engagement.

Requirements:

• The ideal candidate requires a Degree in Life Sciences.
• Expert on all Regulatory Affairs processes, applications and regulatory environment to achieve and maintain marketing authorizations.
• Good knowledge of drug development and the rare diseases regulatory environment.
• Very good knowledge in written and oral English, knowledge of other languages is an upside but not required.
• Seasoned regulatory leader able to manage several program(s) or a very complex program with multiple indications; able to lead major Agency interactions and influence regulatory strategy as well as role model behaviours within the company.
• Interested in people management and development.

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.