Director Pharmacovigilance & Regulatory Affairs – CEE
About The Position
Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases.
Medison has a deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored-solutions for country-specific and regional commercialization, enabling emerging biotech companies to navigate local complexities and to expand their reach to patients in international markets.
Medison is rapidly growing in the international markets backed by 25 years of established operations in Israel, global infrastructure and partnership network. Medison is headquartered in Israel, with its international markets HQ in Switzerland and commercial hubs across the Baltics, Central and Eastern Europe, the Balkans, Greece as well as Canada.
In your role as Director RA & PV CEE, you will be responsible for providing strategic direction for Medison Pharma development programs and licensed products in the CEE market. You will be responsible for preparing regulatory and pharmacovigilance development strategies, advising management on PV/RA risks, and leading interactions with regulatory agencies on behalf of Medison Pharma.
This position involves both high-level strategic planning as well as hands-on responsibilities to support the growing pipeline.
Our preferred location for the role is Switzerland, however we may consider candidates in other Medison Pharma European locations.
- Main responsibilities:
- Develop CEE regulatory and pharmacovigilance strategies aligned with business objectives
- Provide guidance, direction, and leadership on those strategies to the development team and senior management
- Provide vendor oversight and management of PV/RA day to day operations activities
- Make regulatory/PV strategy contributions to clinical development plans
- Assist in the preparation of meeting requests and briefing documents for CEE health authority interactions
- Serve as the primary liaison between the company and the CEE health authorities; coordinate and prepare teams for meetings with regulatory authorities
- Ensure timely submission of safety reports and other external submissions through effective
- Vendor management and performance metrics review
- Maintain up-to-date working knowledge of laws, regulations, and guidelines across the CEE region
- Coordinate and prepare responses to requests for information from CEE regulatory authorities
- Identify and collaborate with regulatory/PV experts and consultants, as needed
- Serve as RA/PV Subject Matter expert (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, metrics, vendor oversight, etc.
- Provide vendors with resources and training
- Represent the CEE regulatory function on cross-functional development teams
- Work with the appropriate partners within the company to establish, update, and implement European regulatory policies, standards, and procedures for the company
- Work closely with Global Regulatory Operations to understand electronic submission process and guide the development team with regard to format and content of CEE regulatory submissions
- Participate in the review of essential documents, presentations, and reports as necessary
- Build a CEE regulatory affairs team in line with Company growth trajectory to support the growing development pipeline and commercial activities
- Liaise with members of the Company’s Quality, Global Regulatory Strategy/PV, CMC, Operations and Ad/Promo/Labeling groups to advance the Company’s development programs
- An advanced degree with a minimum of 10 years of relevant regulatory and pharmacovigilance experience in the pharma/biotech industry, and a minimum of 3 years of experience in a senior RA/PV role
- Prior experience with regulatory/pharmacovigilance aspects of pharmaceutical product commercialization in the CEE market
- Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people
- Excellent working knowledge of drug development, safety & product commercialization process and knowledge of the CEE regulatory/PV requirements (filing experience)
- Strong strategic and analytical abilities
- Electronic submission experience
- Excellent verbal and written communication skills
- Ability to provide strong regulatory & pharmacovigilance leadership on a cross-functional team
- Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development, safety & product commercialization
- Excellent team-building, leadership and management skills
- Excellent listening, communication and interpersonal skills fostering team spirit
- Demonstrated skills in managing direct reports, vendors and others involved in regulatory affairs and pharmacovigilance activities to meet corporate objectives
- Experience in mentoring staff to develop their skills and ensure they remain challenged professionally
- Excellent communication skills, fluent in English, any other European language a plus