Senior Manager (Director), Regulatory Affairs & Pharmacovigilance

Revolutionizing access to medical treatments 

We're on a mission to enable earlier and better access to treatments and improve the lives of patients. Making it possible for anyone to find and access the best possible treatment options, with the click of a button. Bringing together demand and supply like never before, in one of the world's largest industries. Our patient-centered offering is gaining traction, and with the right team we can go from helping thousands of patients to millions of patients access new treatments each year. Do you aspire to be at the forefront of innovation in healthcare and create the next unicorn? You’ve come to the right place!  

The opportunity of Senior Manager (Director), Regulatory Affairs & Pharmacovigilance.

This position is responsible for managing all aspects related to Regulatory Affairs and Pharmacovigilance in connection with Expanded Access Programs (EAPs). Daily activity will include developing regulatory strategies, consulting clients and managing complex projects to prevent, identify, escalate, and solve any obstacles, ensuring EAPs are executed according to plan and in full compliance with the regulatory requirements and client expectations The ideal candidate will have prior proven success in regulatory activity for EAPs, strong analytical abilities, strategic thinking leading to quick and thoroughly thought-out actions, as well as flawless execution, and be a skilled team leader and team player.

You will be actively working together with Program Management, Site Management, Quality Assurance, and Supply Chain and will report into the Director of Expanded Access Operations.

What you will do in this role:  

• Lead the Regulatory Affairs & Pharmacovigilance team, currently consisting of three team members: a Regulatory Affairs Manager and two Documentation Officers working in EMEA.

• Develop, structure, and execute regulatory strategies of EAPs for biologicals, cell therapy, and synthetic drugs. 

• Act as the Subject-Matter Expert for Regulatory Affairs and Pharmacovigilance in various situations: communications with clients (biotech/pharma), Health Authorities and cross-functional teams and support internal/external audits.

• Manage all Regulatory and Pharmacovigilance aspects of EAPs, including the preparation and review of regulatory content for the program portfolio.

• Consult clients on strategy for setting up and executing EAPs globally and/or in specific countries. 

• Structure and maintain an up-to-date working knowledge of Regulatory and Pharmacovigilance regulations and guidelines related to Expanded Access. 

• Support, control, and manage the Pharmacovigilance services offered to clients 

• Be responsible for the creation, review and maintenance of SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective Actions and Preventive Actions) assigned to the department 

• Support the Commercial team on feasibility and qualification of new Expanded Access Programs  

• Provide team members with strong leadership, nurture personal development, and ensure a high performance environment 

Requirements

What you bring to the table: 

• Bachelor’s or Master’s degree in Life Sciences or similar. 

• At least 7 years of work experience in regulatory and pharmacovigilance roles in biotech/pharma, including specific experience in managing global expanded access programs. 

• In-depth knowledge of FDA and EU regulations, GMP and ICH guidelines and ability to implement them within the context of expanded access programs. 

• Experience in effectively managing expanded access teams, including external vendors. 

• Proven experience in mastering effective communication and negotiation skills internally and with regulatory authorities 

• Ability to organize, mentor and motivate the team in a quickly growing and agile/flexible environment  

• Ability to prioritize activities to ensure spending time on the critical priorities, with the highest impact on the organization 

• Ability to plan your work strategically coupled with a