Global Head of Regulatory Affairs

Location
Germany (DE)
Salary
Up to €150,000
Posted
19 Apr 2021
Closes
19 May 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

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

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