Regulatory Affairs Manager

10 month contract

Must be able to work on a W2

Remote, PST hours preferred

Requirements

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.