Regulatory Affairs Manager

Patient Access Collaborative; Oost-Vlaanderen; On-site; EUR 60,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Job summary

Jobtailor is seeking a capable professional to lead BeNeLux regulatory activities for marketing authorizations and to support information/publicity and pharmacovigilance duties.

The role includes medical writing for reimbursement files, RWE collection, and collaboration on Medical Affairs projects with stakeholders across a global landscape.

Qualifications

• Masters or PhD in science or equal through pharmaceutical industry experience.
• Regulatory knowledge of local/EMA requirements is required.
• Exposure to RIP activities is a plus.
• Experience in local/EU GVP is valuable.
• Strong networker with ability to influence stakeholders.

Responsibilities

• Manage BeNeLux regulatory activities to obtain marketing authorizations.
• Support RIP activities including information and publicity.
• Oversee local pharmacovigilance, input to safety reports, and manage ICSR as local QPPV.
• Contribute to reimbursement files via medical writing and budget impact/RWE work.
• Support Medical Affairs projects: patient journeys, training decks, patient/HCP materials.
• Manage stakeholder interactions including advisory boards and presentations.
• Engage in medical information activities, respond to inquiries and report adverse events.
• Coordinate field market access research.

Skills

Regulatory knowledge

Pharmacovigilance

Medical writing

Stakeholder management

Communication

Education

Master/PhD in biomedical/ pharmaceutical sciences

Job description

Responsibilities

• Management of local (BeNeLux) regulatory activities to obtain marketing authorizations for pharmaceutical products
• Management and/or support of activities as Responsible for Information and Publicity (RIP)
• Management of local (BeNeLux) pharmacovigilance activities including input to safety reports and management of ICSR as local QPPV
• Contribution to reimbursement files by medical writing and/or budget impact analysis and RWE collection
• Contribution to Medical Affairs projects such as development of patient journeys, slide decks for training, patient, HCP and marketing materials
• Management of stakeholder interactions including advisory boards and scientific presentations
• Involvement in medical information activities at local and global level. This entails replying to medical enquiries and relevant reporting of adverse events, technical complaints or special situations
• Management of field market access research

Requirements

• Master/PhD degree in science (Biomedical sciences, Biotechnology, Pharmaceutical sciences, Drug Development, Medical Doctor, Biosciences), or equal through experience gained in Pharmaceutical Industry
• Languages: Dutch/French/English (by preference native French or Dutch)
• Previous experience in a pharmaceutical company or an agency providing consulting/clinical services to pharmaceutical industry is required
• Having the technical regulatory knowledge of local/EMA regulatory requirements is required
• Having previous exposure to RIP activities is a clear asset
• First experience with local / EU GVP requirements is valuable
• Strong interest to develop market access and medical affairs skills is required
• Excellent stress and time management and ability to handle priorities and deadlines
• Strong networker with ability to influence internal and external stakeholders
• Team player - accountable and entrepreneurial