Regulatory Affairs & Pharmacovigilance Manager
About The Position
Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. 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 and Australia.
The Regulatory Affairs and Pharmacovigilance Manager will be responsible for all regulatory and PV activities in the territory.
The candidate will have the ability to thrive in an environment of rapid change; work effectively within cross-functional teams and have a passion for highly innovative therapies that can dramatically improve patients' lives.
He/she will be responsible for all regulatory activities including preparation and execution of comprehensive plans for submission of regulatory dossiers and take an active part in building a compliant and efficient Quality Management System, in accordance with local regulations and guidelines, and procedures to cover the relevant GxP activities in the territory. He/she will also oversee all discussions and negotiations with local vendors and the health care authorities taking regulatory responsibility for the products within the territory.
He/she will maintain and oversee pharmacovigilance activities in the territory in accordance with applicable regulations.
He/she will be part of the APAC Tech Ops team.
Areas of Responsibility
- Lead development, implementation and maintenance of regulatory strategic plans, submission processes and negotiations with the local Health Authority (HA) to deliver regulatory approvals for Business Unit objectives
- Create procedures (SOPs) for QA, RA and PV activities in the territory in compliance with Medison policies, local regulations and Good Regulatory Practice
- Serve as the Responsible pharmacist to local agencies, as applicable
- Oversee, maintain ain and execute batch release procedures
- Ensure proper training of staff regarding QMS, compliance and PV and ensure awareness of drug safety reporting
- Maintain the relevant expertise and knowledge of local regulations and requirement to ensure compliance of Medison regulatory affairs in the territories
- Establish priorities and budgets
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Routinely communicate with the Country Manager to directly ensure the regulatory requirements and planning are executed and adapt to align with the new business development targets and lifecycle phase of the product.
- Represent the organization with senior level internal & external stakeholders.
- Ensure Health Professional communications, public communications, promotional materials and press releases are aligned to corporate positions and policies, and compliant with regulatory requirements.
- Support global quality management in auditing and monitoring activities to ensure an effective quality management system; work with business to document deviations and to develop/implement corrective actions plans.
- Establish and maintain local pharmacovigilance system and procedures covering all activities, including risk management, required by regulations and safety agreements with partners.
- Serve as the local PV contact (QPPV) to the local agency.
- Perform local translations of ICRS, PSUR, RA correspondence, regulatory intelligence as required, and oversee the activity where translation service is outsourced.
- Manage AEs and safety information in the territory and perform/support regulatory submission.
- Participate in global meetings with partners if requested, provide technical and strategic input.
Required Education and Experience:
- Minimum requirement: Bachelor’s Degree in Pharmacy
- Additional requirements: minimum of 8+ years pharmaceutical industry experience with at least 5-years in Regulatory Affairs and at least 3 years in PV
- Experience in a start-up biotech or mid-sized innovative healthcare organization preferred.
- Experience in managing and interfacing effectively with CEO Staff level stakeholders, negotiating and synthesizing messages.
- Experience in hands-on batch release activities
- Local language and English language a must and overall strong communication skills
- Strong problem solving and analytical skills
- Ability to work in a highly dynamic and fast-growing organization with demonstrated capability to be at ease in a matrix structure with ability to influence