Director, Regulatory Affairs Operations

About the Role >>> Director, Regulatory Affairs Operations    

As the Director of Regulatory Affairs Operations, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will develop and lead global regulatory operations to support the advancement of multiple clinical trials. This role provides leadership in the 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. 

This role is based out of our Cambridge, MA office and may require 15% travel. 

Your work will primarily encompass: 

• Serve as the 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.  
• Assist the Global Regulatory Lead in meetings for response to Heath 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, JNDA/BLAs and other regulatory submissions. 
• Conduct operational risk assessments and develop robust mitigation measures. 
• Maintain and track all regulatory submissions to Health Authorities and the Health Authority correspondences. 
• Identify, implement, and administrate enterprise document management systems and publishing tools such as: file transfer, tracking and archival.
• Provide expert support and guidance on Regulatory Information Management to the teams.
• 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 the Head of Regulatory Affairs and Quality Assurance in Departmental Operations and vendor management.

Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• BS or MS in a relevant discipline is required. 
• Knowledge and experience of eCTD submissions. 
• Knowledge and experience with enterprise document management systems (eDMS), preferably Veeva regulatory information management.
• Knowledge of U.S. and international regulations including cGMP, GCP, GPV, GLP, ICH guidance documents.
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking. 

Experience: 

• Minimum 10 years pharmaceutical industry experience in Regulatory Affairs.
• People management experience is preferred. 
• Demonstrated leadership skills while working in a fast paced and changing environment. 
• Experience in build and submission of NDA/BLA and life-cycle management is highly desirable.  

Attributes: 

• Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working.  
• Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines.
• Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives. 
• Excellent written and verbal communication skills.
• Excellent negotiation and organizational skills.

The base pay range for this position is expected to be $225,000 - $235,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

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