G&L is seeking a skilled, mid-level Regulatory Affairs CMC professional to support the authoring of various global post-approval CMC submissions for plasma protein therapeutic products. This role is solely focused on authoring the Chemistry, Manufacturing, and Controls (CMC) sections of the Common Technical Document (CTD). Our ideal candidate has experience authoring CMC CTD sections of complex biological product submissions, with preference for experience specifically with blood products. However, experience with other biological products such as antibody-drug conjugates (ADCs), monoclonal antibody products, or vaccines will be considered. Technical expertise is foundational to this role but ideal candidates will possess the collaborative spirit and critical thinking skills to align with our clients' strategic vision while bringing an independent, impactful perspective.
Key Responsibilities:
Author CMC sections of the CTD for global regulatory submissions, ensuring high standards and compliance with local and international requirements.
Collaborate with client teams to understand and execute their strategic approach, maintaining a proactive role in guiding regulatory direction.
Challenge and refine approaches through knowledge-sharing, critical questioning, and application of best practices within CMC regulatory science.
Support post-approval regulatory activities by staying up-to-date on evolving eCTD standards and providing expertise in document submission requirements for plasma protein therapeutics.
Qualifications and Experience:
7-15 years of CMC authoring experience within regulatory affairs, focused on post-approval biologics.
Proven experience with complex biologics, ideally in plasma protein therapeutics, ADCs, (MABs) or vaccines.
Demonstrated expertise in global regulatory requirements and CTD authoring for US, EU and International markets.
Ability to collaborate effectively with cross-functional teams and communicate regulatory insights in alignment with broader strategic goals.
Soft skills are essential, with a proven ability to integrate seamlessly within internal teams, offering insight without compromising client vision.
Ideal Candidate:
A mid-level professional who understands the nuances of the biologics regulatory landscape and is comfortable working in a team setting and understands the intricacies of working in a client/ consultant relationship. This role is ideal for individuals ready to contribute to a dynamic, global team while maintaining competitive flexibility and ambition.
Apply today to join our team and make a difference in advancing complex biologics globally! This role can be based in either Madison NJ, San Diego CA, London UK, Belfast UK, Barcelona ES