Job Descriptions

Key responsibilities for this role include:

• Subject Matter Expert in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory compliance:
  • Maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to Viatris development programs.
  • Actively collaborate within both the Technical Regulatory function and wider GDD on the development of regulatory strategies for combination products and medical devices.
  • Lead project teams in their awareness of current regulatory best practice when building device development plans.
  • Provide mentoring for, and support the development of, the Technical Regulatory team.

• Lead the program team in the implementation and execution of strategies and plans that ensure compliance to regulations, legislations, standards and regulatory guidelines:
  • Collaborate within program teams to ensure regulatory strategies are disseminated and understood and aligned with the key milestones and critical path activities of the program.
  • Collaborate within Device Program Teams (DPTs) to generate regulatory plans (e.g. meeting requests, submissions etc.). which are aligned with the overall program level timelines.
  • Drive the authoring and review of documents for regulatory submissions; including, but not limited to, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), Marketing Authorisation Applications (MAAs), variations and other related activities (e.g. meeting requests, planning and execution).
  • Ensure timely feedback to GDD Management Team (MT) and DPT on the outcomes of meeting / agency feedback with consideration to program and portfolio level consequences.

The minimum qualifications for this role are:

• Bachelor’s degree in a scientific/engineering discipline. A Masters or higher degree desirable.
• Minimum 8 years’ experience in the Medical Device and/or Drug-Device Combination Product industry.
• Advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements regulatory plans and high-level strategy planning including but not limited to 21 CFR 820 and MDR (EU) 2017/745.
• Knowledge of global Medical Device and Drug-Device Combination Product quality requirements including but not limited to device design controls in accordance with ISO 13485 and 21 CFR 820.30.Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus.
•  Experience, at a team level, in device development programs, specifically with a focus on the preparation and delivery of technical regulatory strategy and content.
• Demonstrable track record of competence in leading device program teams in problem solving approaches to technical regulatory issues.
• Knowledge of the impact of device manufacturing processes in device development
• People management experience a distinct advantage.
• Excellent communicator; clear and concise in communications, both written and verbal.
• Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the department.
• Proficiency in speaking, comprehending, reading and writing English is required.

Skills

• Technical Competencies
• People Management
• Management Skills
• Team Player

Experience

• 8+ years