Manager, Regulatory Affairs Operations

The Manager Regulatory Affairs Operations is responsible for supporting the preparation, coordination, and submission of regulatory filings to global health authorities, with a focus on U.S. FDA submissions.

Responsibilities:
- Collaborate to develop and maintain comprehensive global submission content plans (dossier structure, deliverables, timelines, approval milestones).
- Conduct scenario planning to evaluate regulatory strategies, optimize submission timelines, and mitigate risks.
- Lead coordination and execution of regulatory submissions, including BLAs, INDs, and responses to Health Authority requests.
- Partner with cross-functional teams (CMC, Nonclinical, Clinical, Labeling, etc.) to align submission content and timelines.
- Support preparation, submission, and defense of major U.S. marketing applications (e.g., BLA).
- Participate in and/or lead QC for submissions to ensure accuracy, completeness, and compliance (e.g., eCTD standards) within timelines.
- Manage submission records, documentation, and archiving in RIMS for assigned programs.
- Support transition to and optimization of Veeva RIM (process alignment and user adoption).
- Monitor evolving regulatory requirements and industry trends (e.g., ePublishing/submission standards) and communicate impacts.
- Support management of external vendors (ePublishing providers and regulatory service partners); assist with contract administration (POs and budget monitoring).

Qualifications:
- Bachelor’s degree in biochemistry, chemistry, biology, or related field (advanced degree preferred: PhD/PharmD/MS).
- 3–5+ years regulatory experience in biotech/pharma (biologics preferred).
- U.S. FDA submission experience (BLA/IND) and strong eCTD knowledge.
- Demonstrated submission planning, coordination, and lifecycle management experience.
- Experience with Regulatory Information Management Systems (Veeva RIM).
- Knowledge of ePublishing processes and vendor coordination.
- Strong attention to detail, organization, project management; ability to manage multiple competing deadlines.
- Proactive problem-solving; excellent communication and cross-functional collaboration.

Application instructions: Not provided.