Senior Manager, Regulatory Affairs Operations

Role Summary

Senior Manager of Regulatory Affairs Operations providing global regulatory operations support for 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.

Responsibilities

• Serve as a Regulatory Operations Lead on project submission planning and submission processes, while 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 accuracy of content.
• 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 response 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 Health Authority correspondences.
• 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 the planning, coordination, and execution of strategic technology initiatives, ensuring deliverables are developed, aligned, and executed effectively across functions.
• Advise and train on acceptable eCTD and document publishing formats to ensure compliance globally across industry standards.
• 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 the management of the departmental budget, contracts, invoices and POs.

Qualifications

• BS or MS in a relevant discipline is required.
• Knowledge and experience of eCTD submissions.
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM.
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking.
• Minimum 6+ years pharmaceutical industry experience in Regulatory Affairs.
• Demonstrated leadership skills in a fast-paced and changing environment.
• Experience in build and submission of NDA/BLA and life-cycle management is highly desirable.
• Displays strong proactive acumen and inclusive engagement to drive decision making, turnaround time improvement and effective ways of working.
• Influences cross-functional teams to adopt fit-for-purpose solutions to meet timelines.
• Ability to analyze multiple complex sources and develop recommendations from scientific and operational perspectives.
• Excellent written and verbal communication skills; excellent negotiation and organizational skills.

Education

• BS or MS in a relevant discipline