Senior Manager (Director), Regulatory Affairs & Pharmacovigilance

Job Description

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
  
  

Job 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 high willingness to also take action yourself
• Proven ability to solve complex issues, get to the root cause, foresee potential issues, and proactively mitigate before they happen.
• Excellent verbal and written communication skills in English.
  
  

What We Offer

• Serve a purposeful mission: helping patients gain access to potentially lifesaving treatments
• International work environment, scale-up energy, and flat organization
• Competitive salary, annual performance bonus and equity
• Great career development opportunities in a growing company
• Learning and development budget, alongside internal knowledge-sharing sessions
• Health benefits (medical, dental, and vision)
• 401(k) matching to help you invest in your future
• Remote working
• Policies to support working parents
• Unlimited access to professional guidance by certified psychologists via OpenUp
  
  

Who We Are

myTomorrows aims to break barriers for eligible patients seeking information about clinical trials and support referrals to trial sites. When patients are not eligible for clinical studies, we help them and their physicians to navigate the complexities of expanded access programs.

We are an ambitious, values-driven HealthTech company that empowers patients & physicians to discover & access clinical treatments in development – so tomorrow’s treatments can reach those who need it today. Wherever you are, whichever role you play, you’ll share each & every day with committed, inspired, & innovative teammates.

myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves and we go to great lengths in supporting our team members to be just that.