Senior Manager, Regulatory Affairs Operations

Role Summary

Senior Manager of Regulatory Affairs Operations, reporting to the Director of Regulatory Affairs Operations, provides global regulatory operations support for the advancement of multiple clinical trials. Leads operational guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. Based in San Francisco or Cambridge with 10-15% travel.

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’s pipeline (review clinical protocols, informed consent forms, Investigator’s 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 to ensure accuracy, applicability, consistency, and control of regulatory documents. Interact with SMEs for accuracy of content.
• 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 to INDs, CTAs, IMPDs, NDAs and other regulatory submissions.
• Maintain and track all regulatory submissions to Health Authorities and the corresponding communications.
• Provide formatting and QC checks against company style guides and standards to ensure consistency and high quality of finalized 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, ensuring deliverables are developed, aligned, 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, working practices, and quality controls.
• Monitor changes in regulations and keep project teams and management informed of such changes.
• Maintain expertise with current and future global regulatory submission standards and their implementation within Olema.
• Build strong partnerships with functions and key stakeholders within Olema, and share knowledge and expertise with teams.
• Assist in the Director of Regulatory Affairs Operations in managing the departmental budget, contracts, invoices, and POs.

Qualifications

• Required: BS or MS in a relevant discipline.
• Required: Knowledge and experience of eCTD submissions.
• Required: Knowledge and experience with enterprise document management systems, preferably Veeva RIM.
• Required: Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking.
• Experience: Minimum 6+ years pharmaceutical industry experience in Regulatory Affairs.
• Experience: Demonstrated leadership skills in a fast-paced and changing environment.
• Experience: NDA/BLA build and submission and lifecycle management is highly desirable.
• Attributes: Proactive, inclusive engagement; ability to drive decision making and improve turnaround times; cross-functional collaboration; strong analytical and communication skills; negotiating and organizational skills.

Skills

• Regulatory submissions (eCTD) and global submission standards
• Regulatory operations leadership and cross-functional collaboration
• Document management systems (Veeva RIM) and regulatory technologies
• Regulatory strategy planning and project coordination
• Quality assurance and formatting for regulatory documents
• Effective communication, negotiation, and stakeholder management

Education

• BS or MS in a relevant discipline