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Senior Regulatory Affairs Strategist, Oncology - USA

Contract: W2 role, Full time

Closing Date: 30/06/24

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We are looking for seasoned regulatory professionals to join G&L’s team of therapy area SMEs. We help our clients develop their global regulatory strategy for a portfolio of Oncology products – from development through to life cycle management.

G&L has various projects across 2024 and we always want to hear from professionals who are planning a career move and would like to explore options.

The Role

Typical duties will include:

  • Developing US or RoW Regulatory strategy for Oncology products in development and through life cycle management.
  • Working in a team to plan the strategic direction, providing leadership for interactions with FDA and other global Regulatory authorities.
  • Responsibility for submissions of Regulatory dossiers to global Health Authorities (IND, BLA, NDA, and supplements) ensuring high standards and compliance.
  • Authoring various Regulatory documents (for example new INDs, FDA briefing books, BT Designation requests, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA.
  • Providing strategic direction and content for Regulatory Labeling requirements.

Requirements

Our ideal candidate would have:

  • 7-15 years of experience in Regulatory Affairs, with 3-5 years working with oncology products.
  • A comprehensive understanding of the drug development process and understanding of scientific content and complexities related to a project in Oncology.
  • Experience in developing Regulatory strategies and leading multi-disciplinary teams through FDA interactions.
  • Prior experience working as a consultant, or working successfully in a matrix environment and leading teams successfully toward drug approvals.

G&L Consultants are known for being strong team players, who are confident to communicate their opinions, facts, and thoughts with clarity, transparency, and honesty.

We have high expectations of our colleagues, and our clients expect outstanding standards – both with results that are achieved, and also by looking for opportunities for continuous improvement.

How to Apply

For further details, please send your CV to: talent@gandlhealth.com

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

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