Senior Manager, Regulatory Affairs Operations

Role Summary

Senior Manager, Regulatory Affairs Operations — provide global regulatory operations support for the advancement of multiple clinical trials, leading operational guidance within cross-functional teams and supporting interactions with global health authorities and corporate partners.

Responsibilities

• Serve as a Regulatory Operations Lead on project submission planning and submission processes, proactively managing critical operational issues and ensuring timely submission.
• Provide regulatory operations expertise and leadership to cross-functional teams supporting Olema‚Äôs pipeline (review clinical protocols, informed consent forms, Investigator‚Äôs Brochures, CMC, site documentation, etc. for regulatory compliance).
• Oversee and prepare documentation to support global regulatory filings to ensure accuracy, applicability, consistency, and control of regulatory documents; interact with SMEs for content accuracy.
• Prepare documentation to support global regulatory filings; interact with SMEs for content accuracy.
• Assist the Global Regulatory Lead in meetings for responses to Health Authority requests, content verification, and follow-ups with functional leads.
• Coordinate and prepare responses to Requests for Information from health authorities.
• Provide regulatory eCTD submission support for INDs, CTAs, IMPDs, NDAs, and other regulatory submissions.
• Maintain and track all regulatory submissions to Health Authorities and corresponding communications.
• Provide formatting and QC checks against company Style Guides to ensure high-quality submission documents.
• Provide support and training for Regulatory technologies including Veeva RIM, Veeva Promomats, and StartingPoint templates.
• Assist with planning, coordination, and execution of strategic technology initiatives; ensure deliverables are developed and executed across functions.
• Advise and train on acceptable eCTD and document publishing formats to ensure global compliance.
• Perform quality assurance of submission documents and published output to ensure compliance with global eCTD requirements.
• Assist with development and implementation of regulatory processes related to submission standards, practices, and quality controls.
• Monitor regulatory changes and keep project teams and management informed.
• Maintain expertise with current and future global regulatory submission standards and their implementation at Olema.
• Build strong partnerships with functions and key stakeholders; share knowledge and expertise.
• Assist in the Director of Regulatory Affairs Operations‚Äô management of the department budget, contracts, invoices, and POs.

Qualifications

• Required: BS or MS in a relevant discipline.
• Required: Knowledge and experience of eCTD submissions; experience with enterprise document management systems, preferably Veeva RIM; understanding of global standards and validation concepts, including eCTD and registration tracking.
• Experience: Minimum 6+ years in pharmaceutical Regulatory Affairs; demonstrated leadership in fast-paced environments; experience in NDA/BLA submissions and life-cycle management is highly desirable.
• Attributes: Proactive, inclusive engagement; ability to influence cross-functional teams; strong analytical and communication skills; excellent negotiation and organizational skills.

Skills

• Regulatory submissions (eCTD), global health authority interactions, and document management
• Cross-functional collaboration and project leadership
• Regulatory technology proficiency (Veeva RIM, Veeva Promomats)
• Quality assurance and document formatting per style guides

Education

• BS or MS in a relevant discipline