Senior Manager, Regulatory CMC

Position Summary

Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast-paced and collaborative team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for working with the cross-functional team to lead and support regulatory submissions and activities in the US and globally to support development programs.

Responsibilities

• Proactively manage CMC aspects of clinical products in early-to-late development to create high quality regulatory submissions that support product development strategy.
• Author and review CMC modules of applications and amendments for submission, ensuring complete regulatory content that meets current regional requirements.
• Represent Regulatory Affairs on cross-functional project teams.
• Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes.
• Establish and implement internal regulatory processes, author and review SOPs and Work Instructions.
• Cook up and prioritize regulatory activities and associated resources, ensuring they are functional, consistent, and integrated to reflect cross-functional dependencies.
• Determine risk assessment and implement regulatory strategies for products in early-to-late development.
• Ensure regulatory compliance with relevant regulations.

Qualifications

• Strong knowledge and experience in interpretation of global regulatory requirements, with particular emphasis on the US region.
• Strong organizational skills and the ability to track multiple timelines in parallel and manage deadlines.
• Excellent written and verbal communication and ability to collaborate across functions.
• Strong problem-solving skills and attention to detail.
• Experience communicating regulatory strategies to stakeholders.
• Demonstrated regulatory affairs experience commensurate with the role; BA/BS in a scientific field and a minimum of 6 years of relevant experience.
• Industry experience in CMC development of biologics preferred.
• Experience with a regulatory information management system, such as Veeva Vault RIM a plus.