Responsibilities

  • Direct and oversee short-term and long-term planning of regulatory submission initiatives.
  • Interpret corporate policy.
  • Develop and implement strategies for the earliest possible approval of regulatory submission.
  • Manage regulatory teams and provide guidance.
  • Review and change ongoing projects as needed.
  • Plan, schedule and direct activities and programs through regulatory staff.
  • Negotiate with outside agencies as needed to resolve key regulatory issues.
  • Expedite approvals of product and services.
  • Prepare responses to inquires from regulatory authorities.
  • Communicate changes and updates to staff and management.
  • Prepare and submit applications and reports.
  • Submit supplements and amendments to update registered product information.
  • Monitor and update national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel.
  • Hire, train, and supervise regulatory staff.
  • Handle budget requirements and monitor project and program costs.
  • Review, evaluate, and compile files and reports for submission.
  • Coordinate and prepare document packages for regulatory submissions ensuring compliance with the Food and Drug Administration.
  • Prepare outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.
  • Provide guidance to project teams and staff.

Experience

– Senior experience in the field of Regulatory Affairs, and more particularly
concerning the clinical-regulatory aspects of development and life-cycle management,
ideally on organic products
– Knowledge of CCDS/labelling aspects
– Control of clinical variations
– English proficiency.
– Experience of supervising employees
– Autonomy requested

Qualification

– Life cycle management
– 1 product in development, therefore ability to review investigator brochure, clinical study protocols, IMPD
– Management  if no experience open to the profile with an appetite for management
– 2 days on site mandatory per week

Clinical Regulatory Manager 515