Select your language

US Regulatory Affairs Strategist - USA

Contract: W2 role, Full time

Closing Date: 30/06/24

Apply Now

G&L is looking for experienced Regulatory Affairs strategists to join our team of senior consultants. 

This position involves guiding our clients through their Regulatory plans from creation to approval, working closely with internal G&L and external client stakeholders.

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

The Role

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.

Requirements

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.

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.

Apply Now

Ready to reach your potential?

Discover how G&L can help you do business better

Contact Us