Proactively manage 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, including authoring 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 to relevant regulations.

Requirements

BA/BS in a scientific field and 3-5 years of relevant experience.
Knowledge and experience in interpretation of regulatory requirements, with particular emphasis on US regulations.
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 CMC development of biologics preferred.
Experience with a regulatory information management system, such as Veeva Vault RIM a plus.

Benefits

Health insurance
401(k) matching
Professional development opportunities
Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory submissionsclinical protocol evaluationrisk assessmentregulatory complianceSOP authoringwork instructions authoringregulatory strategy communicationbiologics CMC development

Soft Skills

organizational skillswritten communicationverbal communicationcollaborationproblem-solvingattention to detail