Regulatory Affairs Lead

7 days ago

London, Greater London, United Kingdom Parexel Full time

About the Role

We are seeking a highly skilled Regulatory Affairs Lead to join our team at Parexel. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the successful development and approval of our medical device and combination product portfolio.

Key Responsibilities

  • Develop and implement regulatory strategies for complex combination product programs, ensuring compliance with global regulatory requirements.
  • Provide regulatory guidance and advice to development teams, ensuring that regulatory risks are identified and mitigated.
  • Prepare and review regulatory design control deliverables, ensuring that they meet the required standards.
  • Lead and/or support global filing and lifecycle management activities for device aspects of combination product submissions.
  • Contribute to product development planning, including strategies to bridge delivery systems during development and post-approval changes.
  • Identify and manage issues and opportunities that impact submissions timelines, ensuring appropriate communication, resolution, and/or escalation as needed.
  • Ensure regulatory plans are monitored, progress/variance communicated to Management, and any risks are highlighted.
  • Lead and/or support device-related health authority interactions, ensuring that regulatory requirements are met.
  • Provide regulatory impact assessments for proposed product changes, ensuring that they are aligned with business objectives.
  • Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.
  • Contribute to internal regulatory processes and procedures for medical devices and combination products.
  • Engage with regulatory bodies and industry groups to influence industry standards and regulations, ensuring that the company's best interests are represented.

Requirements

  • University degree in a scientific or engineering discipline.
  • At least 5 years of relevant medical device and/or combination product regulatory experience required.
  • Solid understanding of and experience with global regulatory requirements for combination products and drug delivery systems.
  • Working knowledge with technical/industry standards related to drug delivery systems, such as autoinjectors, pumps, etc.
  • Proven experience in drug/device combination product regulatory approvals.
  • Demonstrate strategic thinking, initiative, change agent leadership, and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies.
  • Ability to synthesize and critically analyze data from multiple sources.
  • Strong interpersonal skills and the ability to deal effectively with a variety of business areas, including medical, scientific, and manufacturing.
  • Demonstrates excellent communication and influencing skills internally and externally, and in particular the ability to impact and influence decisions on global teams, both written and verbal, in English.

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