GPRM/RegCMC Senior Manager

Swiss Franc0000 - Swiss Franc110 per hour
  1. Permanent
  2. Senior/Director & VP
  3. Switzerland
Bern
Posting date: 06 Feb 2019
RA.JF.21588_1549452965

ProClinical is advertising an exciting opportunity for a position as Global Program Regulatory Manager with a top 10 global pharmaceutical company. Specialising in the development of biological therapies, this company is seeking a hard-working and dedicated individual to join their team as Global Program Regulatory Manager (GPRM) in Switzerland.

The GPRM will oversee the operational execution of specific regulatory deliverables relating to world-wide maintenance, upkeep, and lifecycle management of assigned global portfolio brands. This may include preparing all necessary supporting documentation for EU license renewals, EU variations, PSUR submission, addressing HA requests and leading preparation of HA responses, managing interactions with RA colleagues in COPs, participating in regulatory sub-teams, preparing IND/NDA Annual Reports & DSURs. Furthermore, they will maintain product licenses world-wide for assigned registered products.

Job Responsibilities:

  • Leading and coordinating 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), and PSUR submissions for assigned registered products.
  • Providing operational support to the Global Program Regulatory Director and/or the Global Therapeutic Area Leader in addressing compliance-related issues arising on Established Medicines portfolios, including input to Urgent Safety Restrictions (USR) and the preparation of internal and external communication documents to the EU Has involving multiple countries.
  • Leading/providing input to solve regulatory issues related to assigned registered products, as appropriate.
  • Leading the HA Response Team through the regulatory maintenance processes. Representing RA in negotiations with HA in EU in liaison with DRA or CPOs.
  • Providing prompt and complete responses to regulatory relevant queries from various stakeholders (e.g., Has, CPOs) relating to assigned brands.
  • Managing the interaction with RA colleagues in Country organisations.
  • Partnering with US GPRM in preparation of IND/NDA Annual Reports and US PI changes driven by CDS update for assigned Established Medicine brands.

Skills and Requirements:

  • At least a bachelor's degree or equivalent, preferably in a related field.
  • Extensive experience in medical device regulatory affairs.
  • A thorough knowledge of European regulatory environments.
  • Strong strategic and analytical abilities, diplomacy, negotiation, and excellent oral and written communications skills; highly organised.
  • A proven ability to interact in a group environment, with strong interpersonal skills and the ability to establish and maintain effective relationships with all stakeholders.
  • Excellent written and oral communication skills; a detail-oriented work style and the ability to handle multiple tasks.
  • An ability to work under pressure and meet deadlines.
  • An ability to present fact and recommendations in oral and written form.
  • Proficiency with Microsoft Office; additional experience with databases and report writing is a plus.
  • A strategic and team building mindset, with good business acumen and a hands-on approach.
  • Excellent communication, presentation, and persuasion skills, along with the ability to effectively interact with all levels of the organisation.
  • A willingness and availability to travel on company business.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Jay Foster on +44 203 752 0309 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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