Senior Manager, Regulatory Affairs Operations

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.  

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond. 

You can view our latest corporate deck and other presentations here.

About the Role >>> Sr. Manager, Regulatory Affairs Operations     

As the Senior Manager of Regulatory Affairs Operations, reporting to the Director of Regulatory Affairs Operations, you will provide global regulatory operations support for 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 either our San Francisco or Cambridge office and requires approximately 10-15% travel.

Your work will primarily encompass:  

• 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 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 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 PO’s. 

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, preferably Veeva RIM.
• 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. 
• 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 $175,000 - $190,000 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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Important Information >>>

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Fraud Alert:  We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.