Manager, Regulatory Affairs Operations
About The Position
The Manager Regulatory Affairs Operations is responsible for supporting the preparation, coordination, and submission of regulatory filings to global health authorities, with a strong focus on U.S. FDA submissions. This role collaborates closely with Regulatory Affairs and cross-functional teams to ensure the timely and compliant delivery of high-quality regulatory submissions, including major marketing applications (e.g., BLAs) and investigational applications (e.g., INDs). Key responsibilities include developing and managing submission content plans, preparing regulatory submission documents (e.g., cover letters, FDA Forms), overseeing submission timelines, and coordinating publishing activities. The role requires a highly detail-oriented, proactive individual who can effectively manage multiple priorities in a fast-paced environment.
Requirements
- Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field is required; an advanced degree (PhD, PharmD, MS) is strongly preferred.
- Minimum of 3-5 years of regulatory experience in the biotech or pharmaceutical industry, with a focus on biologics, is strongly preferred.
- Experience supporting U.S. FDA submissions (e.g., BLA, IND) and strong understanding of eCTD requirements.
- Demonstrated experience in submission planning, coordination, and lifecycle management.
- Must have experience with Regulatory Information Management Systems Veeva RIM
- Knowledgeable with ePublishing processes and vendor coordination.
- Strong attention to detail, organization, and project management skills.
- Ability to manage multiple complex projects with competing deadlines.
- Proactive mindset with strong problem-solving capabilities.
- Excellent communication and cross-functional collaboration skills.
Nice To Haves
- Advanced degree (PhD, PharmD, MS)
- Focus on biologics
- Experience with Veeva RIM
- Knowledgeable with ePublishing processes and vendor coordination.
Responsibilities
- Collaborate with cross-functional teams to develop and maintain comprehensive global submission content plans, including dossier structure, key deliverables, timelines, and projected approval milestones.
- Conduct scenario planning to evaluate alternative regulatory strategies and recommend approaches to optimize submission timelines and mitigate risks.
- Lead the coordination and execution of regulatory submissions, including BLAs, INDs, and responses to Health Authority requests.
- Partner with functional teams (CMC, Nonclinical, Clinical, Labeling, and others) to ensure alignment on submission content and timelines.
- Support the preparation, submission, and defense of major U.S. marketing applications (e.g., BLA).
- Participate in and/or lead quality control (QC) activities for regulatory submissions to ensure accuracy, completeness, and compliance with regulatory requirements (e.g., eCTD standards).
- Ensure all submission components meet internal quality standards and are delivered within established timelines.
- Manage regulatory submission records, documentation, and archiving within the Regulatory Information Management System (RIMS) for assigned programs.
- Support the organization’s transition to and optimization of Veeva RIM, including process alignment and user adoption.
- Monitor evolving regulatory requirements and industry trends, particularly related to ePublishing and submission standards.
- Assess potential impact of regulatory changes on ongoing and planned submissions and communicate implications to stakeholders.
- Support management of external vendors, including ePublishing providers and other regulatory service partners.
- Assist with contract administration, including creation and tracking of purchase orders and budget monitoring.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
