Job Details

Regulatory Affairs Manager

10 month contract

Must be able to work on a W2

Responsibilities

• Support the development of the nonclinical/clinical regulatory strategy and plan.
• Assist with planning, document development, and meeting execution activities in preparation for health authority meetings/interactions.
• Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with the Regulatory Nonclinical/Clinical (RNC) Lead.
• Collaborate with CROs contracted for regulatory submissions and health authority interactions for global clinical trials.
• With oversight from the RNC Lead, develop and coordinate the core nonclinical/clinical content of regulatory submissions.
• Ensure high‑quality nonclinical/clinical content that adheres to regulations and guidances.
• Lead maintenance of IND/CTAs throughout the lifecycle of studies (e.g., annual reports).
• Assist with preparation of health authority submission packages, including compiling materials such as protocols, annual reports, and briefing books, and completing regulatory documents/forms for internal review.
• Collaborate with Regulatory Project Management to create and align submission timelines.
• Collaborate with Regulatory Operations to provide final documents and perform QC of published outputs for submissions to health authorities.
• Oversee the collaboration of nonclinical/clinical teams with Regulatory Operations to provide final documents and QC published outputs for submissions to health authorities.
• Organize and maintain administrative, nonclinical, and clinical portions of INDs, NDAs, and BLAs.
• Oversee the archiving of health authority submissions and correspondence.
• Lead development of updates to the clinical and nonclinical sections of the core dossier used for international marketing applications.
• Support the RNC Lead in developing nonclinical/clinical portions of required product lifecycle maintenance regulatory submissions, including supplements to approved product dossiers, annual reports, license renewals, and supplemental filings.
• Coordinate interactions with international groups in support of international marketing application filings, including meetings to provide RNC guidance/input on agency interactions, submissions, and RTQs.
• Attend relevant functional area and project team meetings.
• Review, understand, and stay up to date on regulations and guidelines relevant to responsibilities.
• Review documents (SOPs, protocols, and reports) related to clinical or nonclinical studies as necessary.
• Ensure project management timelines and trackers accurately reflect submission plans.

Qualifications

• Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred; Master's/Bachelor's acceptable with relevant experience.
• 4+ years of experience.
• Nonclinical/Clinical Regulatory Affairs experience preferred.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Strategy/Planning, Project Management, and Manufacturing