[Hiring] Senior Manager (Director), Regulatory Affairs & Pharmacovigilance @Mytomorrows
Mar 28, 2025 - Mytomorrows is hiring a remote Senior Manager (Director), Regulatory Affairs & Pharmacovigilance. 💸 Salary: competitive salary, annual performance bonus, and stock options. 📍Location: Europe.
Role Description
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
- Managing complex projects to prevent, identify, escalate, and solve any obstacles
- Ensuring EAPs are executed according to plan and in full compliance with 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 actively collaborate with Program Management, Site Management, Quality Assurance, and Supply Chain and report to 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 preparing and reviewing 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.
Qualifications
- 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.
Benefits
- 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.
- Great career development opportunities in a fast-growing company.
- Learning and development budget alongside internal knowledge sharing sessions.
- Attractive pension plan, full premium covered by myTomorrows.
- Hybrid working model.
- Policies to support working parents.
- Healthy lunch at the thriving Amsterdam office.
- Unlimited access to professional guidance by certified psychologists via OpenUp.
- Enjoy monthly events hosted by our vibrant Culture Club as well as an annual ‘myTomorrowland’ 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.
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| 📍 | Be aware of the location restriction for this remote position: Europe |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
💸
competitive salary, annual performance bonus, and stock options
|
Remote
Location
Europe
|
|
Job Type
full-time
|
Posted
Mar 28, 2025
|
| 📍 | Be aware of the location restriction for this remote position: Europe |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
