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
View more
- Discipline
- Regulatory Affairs, Project Management, Regulatory Project Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Director/Executive
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.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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