Our client has a newly created opportunity for a Regulatory Affairs Senior Manager. In this highly influential role, you will be the primary Health Authority contact for all assigned projects.

Organization: Our client is among the global leading biotherapeutics organizations, with operations in 30+ countries and 20,000+ employees worldwide, they are committed to develop and deliver a wide range of lifesaving therapies to treat hemophilia and other primary immune deficiencies, and vaccines to avert influenza. They have applied their solutions in diverse areas such as cardiac surgery, organ transplantation, and burn treatment. The organization has an unrivalled passion and commitment to make a meaningful difference to people’s lives across the globe; now is an opportune time to join this team.

Responsibilities: 

• Act as the main representative to regional health authorities for assigned products.
• Ensure all regulatory activities are consistent with the strategic course of the Global Regulatory Affairs Strategy Team.
• Provide regulatory guidance on regional, regulatory procedures and health authority requirements.
• Lead the preparation and contribution of briefing packages for allocated products.
• Support the GRL specialist while evaluating regulatory requirements to provide suitable regulatory advice.

Knowledge and Skills: 

• BS/MS, scientific background.
• 7 years of experience in the pharmaceutical industry, Biologics/Research & Development experience preferred.
• 3 -5 years of regulatory experience in a regulatory authority- facing role.
• Pharmaceutical/ Industry experience.
• Experience in negotiation and the resolution of issues with regulatory agencies with positive outcomes.
• Strategic and tactical thinking ability, combined with a “hands on” operational approach and business planning orientation.
• Team player that ensures all teams receive the support they need.
• Outstanding communication skills across all teams.
• Excellent problem solving ability.

Contact: Ed Canning