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Role Description

The Senior Manager, Clinical Regulatory will report to the Senior Director, Clinical Regulatory 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.

• Proactively manages regulatory aspects of clinical studies in early-to-late development to create high quality regulatory submissions that support product development strategy.
• Author and review Clinical modules of applications and amendments for submission, ensuring complete regulatory content that meets current regional requirements.
• Represent Clinical Regulatory Affairs on cross-functional project teams.
• Evaluate proposed clinical protocol changes for impact to existing filings and provide strategic regulatory guidance for optimal implementation of changes.
• Establish and implement internal regulatory processes, author and review SOPs and Work Instructions.
• Coordinate, track, 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

• BA/BS in a scientific field and 8+ years of relevant experience.
• Strong knowledge and experience in interpretation of 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.
• Industry experience in development of biologics preferred.
• Experience with a regulatory information management system, such as Veeva Vault RIM a plus.

Requirements

• Equal-opportunity employer.
• Commitment to fair and equitable compensation practices.
• Anticipated base pay range: $140,000 — $190,000 USD.

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