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Principal Regulatory Affairs Specialist

At our Regulatory Affairs department, we focus on harnessing our collective strength to deliver best-in-class solutions that benefit patients and our cross functional partners.

Job Description

Principal Regulatory Affairs Specialists are directly involved in regulatory activities supporting the global commercialization and sustaining of products on the market in compliance with all regulatory requirements.

Responsibilities

  • Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.
  • Engages with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing products. Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
  • Engages with global regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing global regulatory strategies.
  • Leads regulatory filings to support submissions, license renewal and annual registrations.
  • Influences clinical evidence strategy to support labelling content, marketing claims and regulatory compliance.
  • Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes
  • Mentors and coaches other employees within the department and provides leadership support to ensure strong talent development.
  • Keeps abreast of regulatory procedures and changes. Supports industry advocacy activity to shape the future of evolving regulatory requirements. Develops internal procedures to ensure continuous compliance with all regulatory requirements.
  • Develops strategies for earliest possible global approvals of regulatory filings.
  • Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
  • Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Requirements

  • We are looking for a qualified person to Level 8 Bachelor's Degree/Masters or equivalent in Science, Engineering or related discipline.
  • Regulatory experience in Medical Devices and or Pharmaceuticals is desirable, however, candidates with a minimum of 6 year's relevant experience will also be considered.
  • You are a recognized expert, capable of managing large projects or processes.
  • You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
  • You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
  • You collaborate with others and create alignment with team members, at times acting as a team leader.
  • You are a strong coach/mentor and can provide coaching/training to other employees within the RA Department.
  • You set high standards and drive accountability in the execution of your responsibilities and you model ethical behaviour.
  • You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.