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Global Head of Regulatory Affairs

Employer
Barrington James
Location
Canton of Zürich (CH)
Salary
Up to 180,000 CHF
Start date
20 Apr 2021
Closing date
20 May 2021

Job Details

Global Head of Regulatory Affairs

Are you passionate about clinical studies and want to make a difference in the long term? Can we benefit from your international experience? Are you a team player with a hands-on mentality?

Your area of ​​responsibility

  • Management of global submissions for clinical trials, especially for Europe, USA, Russia, India, Japan, etc.
  • Implementation of innovative strategies for different phases during the submission
  • Development of the regulatory affairs team, contact person for any questions regarding GCP-ICH, FDA, EMEA and other global regulations
  • Control of trackers and documents
  • Assumption of other tasks related to clinical studies

Primary Responsibilities:

  • Provides oversight and management of worldwide regulatory submissions for clinical trial authorisation and marketing authorisation (US, Western Europe, Eastern Europe, and Asian regions), including Pre- IND, IND, NDA, 505(b)(2) NDA and ANDA filings, communication with domestic and foreign regulatory agencies to facilitate the review of regulatory applications.
  • Develops and implements innovative regulatory strategies for all development phases of novel and generic drug, biologics and medical device products.
  • Provides leadership to global regulatory team (US, Western Europe, Eastern Europe; develops and implements company policies and SOPs; and is responsible for safety reporting submissions to Regulatory Authorities.
  • Provides regulatory support to representative offices and project team members for compliance with GCP-ICH, FDA regulations, EMA directives and additional foreign laws and regulations.
  • Responsible for management and tracking of regulatory/IRB/EC/REB documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents

Secondary Responsibilities:

  • Prepares and negotiates master services agreements, project agreements, clinical trial agreements, confidentiality and non-disclosure agreements.
  • Provides legal with support for corporate administration and corporate governance, prepares corporate documents, and maintains administration of corporate records in a Regulatory framework.
  • Ensures branch communication in all regions is established and maintained.
  • Participates in the implementation, administration and continuous improvement of clinical GCP quality systems and programs

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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