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.

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.