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Regulatory Affairs Consultant CMC, Biologics - USA

Contract: W2 role, Full time

Closing Date: 30/06/24

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G&L is currently looking for experienced Regulatory Affairs CMC professionals to join our Biotech team in North America. 

This role will include the development and maintenance of the Quality sections of regulatory submissions to support biologics products and portfolios.

You will be tasked with a wide variety of responsibilities including building Clinical trial applications, New marketing applications, HA responses & background packages, and post-approval submissions.

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:

  • Representing regulatory CMC in matrix teams for Biologics pipeline products and commercial products through the completion of post-marketing commitments and relevant lifecycle management projects.
  • Providing strategic guidance and input to regulatory requirements and expectations for Biologics marketing applications, clinical trial applications for projects, and lifecycle changes to marketed products.
  • Independently managing and prioritizing multiple complex projects. Identifying issues and proposing resolutions.
  • Interfacing with Health Authorities for CMC submissions and CMC-related issues.
  • Interpreting global regulations and guidance. Identify regulatory opportunities and risks.
  • Reviewing and providing regulatory assessments on change control.
  • Preparing and managing CMC submissions for global markets while ensuring thoroughness, completeness, and timeliness, including the creation and maintenance of strategy documents.

Requirements

Our ideal candidate would have:

  • Around 10 years experience in the Pharmaceutical industry, with solid experience in CMC regulatory strategy.
  • Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for Biologics products.
  • Knowledge of pharmaceutical development, including drug substance, drug product, and analytical methods.
  • The ability to prepare and manage filings and ensure thoroughness, accuracy, and timeliness.
  • 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.
  • Excellent computer skills, including the ability to utilize electronic systems for dossier creation and tracking.

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.

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