Typical duties will include:

• Working in close partnership with the regional strategists to develop strategic and operational plans for the development and registration of assets.
• Supporting MA submissions teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.
• Planning for contingency to achieve regulatory objectives with associated risks and mitigation strategies.
• Troubleshooting and suggesting new approaches to resolve regulatory issues.
• Building strong relationships with Health Authorities, and supporting interactions by preparing objectives for meetings, outlining briefing material, and facilitating content discussions and input.
• Providing input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP.
• Participating in the assessment of regulatory precedence and regulatory scientific guidelines.
• Leading identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together.

Our ideal candidate would have:

• 5-10 years of regulatory experience, including therapy area expertise; oncology experience would be a benefit.
• Good knowledge of the drug development process, and strong working knowledge of policy, laws, regulations, and guidelines.
• Excellent interpersonal skills, and the ability to thrive in a cross-functional environment. Confidence to speak up on issues and risks as well as on the good news.

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.

You should be open-minded and agile – be interested in other’s opinions, and ready to act on new information and differing perspectives.