Sr Regulatory Consultant (Biologics/Biosimilars)

As a Sr Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications. Your responsibilities will include: - Authoring and reviewing CMC sections of regulatory submissions such as INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. - Ensuring completeness and compliance of CMC sections within IND and IMPD applications based on regulatory guidance (FDA, EMA, ICH). - Providing peer review and mentorship to junior writers or team members to maintain consistency and scientific accuracy across deliverables. - Staying updated with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars. - Demonstrating a good understanding of analytical method development, validation, comparability, upstream and downstream process development. In addition to the primary skills, the following secondary skills are also required for this role: - Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance. - Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics. Qualifications for this position include: - Minimum of 8 years of experience in CMC-Biologics with a Masters degree in pharmaceutical sciences (preferred) or Masters degree in other life sciences. - Ability to work independently, manage multiple priorities in a fast-paced consulting environment, and strong organizational skills. - Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. At Syneos Health, we are committed to developing our employees, fostering a Total Self culture, and creating a diverse and inclusive workplace where everyone feels valued and respected. Join us in our mission to accelerate customer success and change lives through innovative solutions in the biopharmaceutical industry.,