Associate Director Regulatory Affairs

1 month ago

London, United Kingdom Skills Alliance Full time

Job Description

Job Title: Associate Director, Regulatory Affairs

Main Purpose of Role:

The Associate Director, Regulatory Affairs, plays a pivotal role in providing strategic regulatory and scientific support for pre-clinical and clinical development plans. Collaborating with Regulatory Affairs teams, this role aims to expedite access to innovative medicines for patients efficiently. Responsibilities include regulatory strategy planning, due diligence assessments, regulatory interactions, and contributing to various regulatory processes.

Key Responsibilities:

  • Strategy Planning: Contribute to strategic decisions throughout the life cycle of innovative medicines in the portfolio. This involves assessing clinical data adequacy, preparing briefing packages for regulatory discussions, and actively participating in the development of clinical development plans.
  • Regulatory Review: Review and ensure correctness and adequacy of regulatory documents such as study synopses, protocols, and Module 2.4, 2.5, 2.6, and 2.7 sections. Collaborate with internal and external stakeholders to finalize submission documents and product labels.
  • Clinical Trial Oversight: Provide oversight for clinical trial applications, collaborating with designated Contract Research Organizations (CROs) if ADVANZ acts as a sponsor for clinical trials.
  • Collaborative Work: Work closely with other regulatory teams, Transformation Office Strategic Program Managers, and alliance partners to manage relationships and ensure timely responses to queries. Also collaborate with Clinical, Medical Affairs, and Patient Safety leadership within the Medical office.
  • Team Participation and Development: Actively participate in regulatory team meetings, governance meetings, and contribute to internal training and development initiatives. Stay updated on regulatory changes and propose mitigation strategies for risks or delays.
  • Issue Escalation and Proposal: Appropriately escalate risks or issues that may impact regulatory approval timelines. Propose improvements or alternative approaches to enhance project deliverables.

This role requires a collaborative approach, strong communication skills, and the ability to influence stakeholders across various levels within and outside the organization.

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