For our customer located in Basel/Switzerland we are currently looking for (m/f) an GPRM/RegCMC Senior Manager
- Type of placement: 6 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Department: Drug Regulatory Affairs, Global Health Unit
The Global Maintenance Regulatory Manager (GMRM) is responsible for maintaining the product licences in the European Union countries for our customer´s assigned Pharma registered products across all Business Units and Business Franchises.
Additionally is responsible for the operation execution of specific regulatory deliverables (see below) relating to world-wide maintenance, upkeep and lifecycle management of assigned Established Medicines global portfolio brands on a continual or ad-hoc basis as may be required.
EU Regulatory Maintenance activities
1. Lead and coordinate timely and high quality preparation of all necessary supporting documentation by internal or external experts for EU license renewals, EU variations (except CMC-related variations), PSUR submissions for as-signed Pharma registered products approved via the:
- Centralized Procedure (CP),
- Mutual Recognition Procedure/Decentralized Procedure (MRP/DCP) with the support of the respective Reference Member State (RMS) CPO,
- National Procedure (renewals only - provide documentation as required by the PONERC strategy).
2. Interact with the EU and other Rest of World Health Authorities to solve regulatory issues related to assigned our customer´s Pharma registered products, as appropriate. Lead the HA Response Team through the regulatory maintenance processes. Represent RA in negotiations with HA in EU in liaison with DRA CPOs or Europharm.
3. Manage the interaction with RA colleagues in CPOs and with agents where no CPO exists (e.g. Cyprus) for regulatory maintenance activities.
4. Support EU referral procedures to ensure a smooth progression of the procedure by providing the BF/BU manager with source documents where needed to achieve the best possible labelling harmonization across EU.
Regulatory activities related to assigned Global Health global portfolio brands
1. Provide prompt and complete responses to regulatory relevant queries from various stakeholders (e.g. HAs, CPOs) relating to assigned brands.
2. Partner with US GPRM in preparation of IND/NDA Annual Reports and US PI changes driven by CDS update for assigned Established Medicine brands.
3. Provide DRA input and collaborate with relevant GLFs, in planning and execution of agreed actions relating to the thorough and efficient management of regulatory procedures across EU, specifically EU referrals and art 45 procedures for assigned EM products.
4. Provide DRA input for pruning, in- and out-licensing initiatives for assigned Established Medicines, worldwide.
5. Collaborate with EMBF Global Marketing and relevant GLFs in creating strategies and action plans to ensure the maintenance of product licenses for assigned EM brands, worldwide.
- University Degree or PhD in Life Sciences, Pharmacy or Medicine
- Fluency in English as business language, additional European languages advantageous
Experience/ Professional requirements
- Minimum 2-3 years experience in EU (or global) regulatory affairs, related areas of the pharmaceutical Industry or Health Authorities
- (Senior): Extensive experience (5-10 years) in EU (or global) regulatory affairs
- Good interpersonal and communication skills, ability to work effectively in a matrix environment