Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA

About myTomorrows

myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options.

We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma - connecting key stakeholders in the drug development ecosystem.

We've developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection.

With a global footprint spanning 125 countries, to date, we've supported over 14,000 patients and 2,200 physicians, earning the trust of 50+ Biopharma companies.

Join us in shaping the future of treatment access - making tomorrow's therapies accessible for people who need them today.

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 the feasibility and qualification of new Expanded Access Programs

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

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

• Impactful work that helps patients gain access to potentially lifesaving treatments.

• International work environment, scale-up energy, and flat organizational structure which encourages creativity and accountability.

• Competitive salary, annual performance bonus, and an Employee Stock Option Plan.

• Health insurance benefits through Cigna.

• 401K where we match 100% of employee contributions up to the first 3% of pay and 50% of employee contributions on the next 2% of pay.

• Great career development opportunities in a fast-growing company.

• Learning and development budget alongside internal knowledge-sharing sessions.

• Remote working model.

• Policies to support working parents.

• Unlimited access to professional guidance by certified psychologists via OpenUp

• An annual 'myTomorrowland' which is a 2-day company-wide celebration!

Equal opportunities

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.