Sr. Manager/Associate Director Regulatory Affairs

Who We Are >>> Why You Should Work With Us

Olema Oncology (OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers. Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer. Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.

Onto something bigger, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer. 

Strategically located in two large biotech hubs – San Francisco, CA and Cambridge, MA – we offer a flexible work environment and the best of both coasts. 

Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses. 

While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.  

We are looking for a driven Sr. Manager/Associate Director, Regulatory Affairs.  You will collaborate with cross functional teams on deliverables.

This is a fantastic opportunity for a hands-on Sr. Manager/Associate Director to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women’s oncology company with significant potential to transform breast cancer treatments.

This role is based out of either our San Francisco, CA or Boston, MA office.

Your work will primarily encompass:

• Project Support: With minimum supervision, assist in overseeing project submission planning and managing timelines, schedules, and regulatory submission processes
  • Collaborate with the cross-functional team leads to prioritize and align deliverables
  • Provide regulatory support to the assigned teams (Review clinical protocols, informed consent forms, Investigator’s Brochures, CMC, site documentation etc.)
  • Provide regulatory operations expertise and leadership to the cross functional teams in a representative function supporting Olema pipeline

• Regulatory Submissions: Oversee and prepare documentation to support regulatory filings to ensure accuracy, applicability, consistency, and control of regulatory documents. Interact with SMEs for accuracy of content
  • Assist with the development of technical documents for regulatory filing
  • Assist the Regulatory Lead in meetings for Response to Heath Authority requests, content verification and follow-ups with functional leads
  • Manage workflows for documents
  • Coordinate and prepare responses to Requests for Information from health authorities

• Operations/Systems: Provide regulatory eCTD submission support to INDs, CTAs, IMPDs. NDAs, JNDA/BLAs and other regulatory submissions
  • 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
  • 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

• Regulatory Intelligence: Monitor changes in regulations and keeps project teams and management informed of such changes. Maintain familiarity with current and future global regulatory submission standards

What You Will Bring:

• Bachelor’s degree in a scientific discipline. Advanced degree is preferred
• At least 8 years pharmaceutical industry experience in Regulatory Affairs
• 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, GLP, ICH guidance documents
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities
• Excellent written and verbal communication skills
• Excellent negotiation and organizational skills

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.

Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!

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