Manager, Regulatory Affairs Operations

Manager Regulatory Affairs Operations

Responsibilities:
- Collaborate with cross-functional teams to develop and maintain global submission content plans (dossier structure, deliverables, timelines, approval milestones).
- Conduct scenario planning to evaluate regulatory strategies and optimize submission timelines while mitigating risk.
- Lead regulatory submission coordination and execution for BLAs, INDs, and health authority responses.
- Partner with CMC, Nonclinical, Clinical, Labeling, and others 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 to ensure submission accuracy, completeness, and compliance (e.g., eCTD).
- Manage regulatory records, documentation, and archiving in RIMS.
- Support transition to and optimization of Veeva RIM (process alignment and user adoption).
- Monitor evolving regulatory requirements and industry trends (ePublishing/submission standards) and communicate impacts.
- Support vendor and ePublishing provider management; assist with contract administration (POs, budget monitoring).

Qualifications:
- Bachelor’s degree in biochemistry, chemistry, biology, or related pharmaceutical field (advanced degree strongly preferred).
- 3–5+ years regulatory experience in biotech/pharma (biologics strongly preferred).
- Experience supporting U.S. FDA submissions (BLA/IND) and strong eCTD knowledge.
- Demonstrated submission planning, coordination, and lifecycle management experience.
- Must have experience with Veeva RIM.
- Knowledge of ePublishing processes and vendor coordination.
- Strong attention to detail, organization, and project management; ability to manage multiple priorities.

Skills/Attributes:
- Proactive, strong problem-solving; excellent communication and cross-functional collaboration.