Description
Global Maintenance Regulatory Manager / Global Program Regulatory Manager - NOVJP (m/f)
Reference: -en
Start: asap
Duration: 7 MM++
Main tasks:
- 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 assigned 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, and/or National Procedure
- Interact with the EU and other Rest of World Health Authorities to solve regulatory issues related to assigned Pharma registered products
- Lead the HA Response Team through the regulatory maintenance processes and represent RA in negotiations with HA in EU in liaison with DRA CPOs or Europharm
- Manage the interaction with RA colleagues in CPOs and with agents where no CPO exists (e.g. Cyprus) for regulatory maintenance activities
- 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
- Provide prompt and complete responses to regulatory relevant queries from various stakeholders (e.g. HAs, CPOs) relating to assigned brands
- Partner with US GPRM in preparation of IND/NDA Annual Reports and US PI changes driven by CDS update for assigned Established Medicine brands
- 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
- Provide DRA input for pruning, in- and out-licensing initiatives for assigned Established Medicines, worldwide
- 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
Main qualifications
- University Degree or PhD in Life Sciences, Pharmacy or Medicine
- Fluency in English as business language, additional European languages advantageous
- Solid experience in EU (or global) regulatory affairs, related areas of the pharmaceutical Industry or Health Authorities
- Good interpersonal and communication skills, ability to work effectively in a matrix environment
Main advantages:
- A very renowned company
- Interesting tasks in a multinational environment
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Svenja Weiß
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