Biologics Regulatory Affairs Manager

Job Title : Biologics Regulatory Affairs Manager

We are seeking an experienced CMC Regulatory Affairs Senior Manager to lead our team in the development and submission of innovative antibody-based therapies. This role will focus on lifecycle management, regulatory engagement, and commercial partnership strategy.

The ideal candidate will have expertise in EU / US product lifecycle variations, analytical development, and CMC documentation. They should be able to make informed decisions about document content and structure for smooth submissions.

Key responsibilities include leading LCM strategy and submission preparation, engaging with regulatory agencies and commercial partners, and writing CMC documentation related to analytical development.

This is a unique opportunity to join our team and contribute to the development of groundbreaking therapies that improve patient outcomes globally.

Requirements include 10+ years of experience in biologics, a strong background in CMC authoring, and excellent communication and leadership skills.

If you are passionate about making a difference in the lives of patients and have the expertise to drive success in this field, we encourage you to apply.

This is a challenging and rewarding role that offers the opportunity to work with a talented team and contribute to the development of innovative therapies.

We value diversity, inclusion, and collaboration, and offer a range of benefits and opportunities for growth and development.

Please submit your application, including your resume and a cover letter, to be considered for this exciting opportunity.

We look forward to hearing from you!