Job Description Template for:

Regulatory Supervisor

Years of experience: 7 - 12 years
  • Master's degree in a scientific discipline.
  • PhD degree in a scientific discipline.
  • Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
  • Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy
  • Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications
  • Provide expert regulatory input to in-licensing evaluations and due diligence activities
  • Provide advice about regulations to manufacturers/scientists
  • Coordinate successful submissions and approval of all applications
  • Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil the quality standards
  • Plan, undertake and oversee product trials and regulatory inspections
  • Keep up-to-date with changes in regulatory legislation and guidelines
  • Write comprehensible, user-friendly, clear product information leaflets and labels
  • Liaise and negotiate with regulatory authorities
  • Develop and establish policies and standards that convey the best practices in the company
  • Review and report overall quality status to the management team
  • Project management of development of new generic products
  • Use a variety of specialist computer applications
Required Skills & Qualifications:
  • Deep experience from pharmaceutical industry from a regulatory affairs perspective
  • Knowledge of pharmaceutical legislation, relevant guidelines, procedures and requirements
  • Fluent in oral and written English
  • IT Skills

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