Senior Manager (Director), Regulatory Affairs & Pharmacovigilance - Remote

Overview

The Senior Manager (Director) of Regulatory Affairs & Pharmacovigilance will manage all aspects related to Regulatory Affairs and Pharmacovigilance in connection with Expanded Access Programs (EAPs), ensuring compliance with regulatory requirements and client expectations.

In Short

• Lead the Regulatory Affairs & Pharmacovigilance team.
• Develop regulatory strategies for EAPs.
• Act as Subject-Matter Expert in communications with clients and Health Authorities.
• Manage all Regulatory and Pharmacovigilance aspects of EAPs.
• Consult clients on strategy for executing EAPs.
• Maintain knowledge of regulations related to Expanded Access.
• Support Pharmacovigilance services offered to clients.
• Create and maintain SOPs, QIs, and CAPAs.
• Support Commercial team on feasibility of new EAPs.
• Provide leadership and development opportunities for team members.

Requirements

• Bachelor’s or Master’s degree in Life Sciences or similar.
• At least 7 years of experience in regulatory and pharmacovigilance roles.
• In-depth knowledge of FDA and EU regulations.
• Experience managing expanded access teams.
• Effective communication and negotiation skills.
• Ability to mentor and motivate teams.
• Strong organizational skills and prioritization abilities.
• Strategic planning and action-oriented mindset.
• Proven problem-solving abilities.
• Excellent verbal and written communication skills in English.

Benefits

• Impactful work in patient treatment access.
• International work environment with creativity and accountability.
• Competitive salary and annual performance bonus.
• Health insurance benefits through Cigna.
• 401K matching contributions.
• Career development opportunities.
• Learning and development budget.
• Remote working model.
• Supportive policies for working parents.
• Access to professional guidance by certified psychologists.