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.

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.