Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity.

Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at

About the Role

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

As the Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs reporting to the Senior Vice President of Regulatory Affairs, your responsibilities will include the following:

• Lead the development of the New Drug Application (NDA)
• Lead the development and execution of innovative regulatory strategies supporting Olema products
• Represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive Committee
• Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)

This role is based out of either our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%.

Your work will primarily encompass:

Lead the development and submission of the NDA for the company's lead program

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed
• Represent Regulatory Affairs on cross-functional teams as the SME and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive committee
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices
• Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)
• Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives
• Identify gaps and develop risk mitigation strategies for the regulatory submissions
• Ensure Olema’s regulatory activities are robust and are in compliance with Health Authority (HA) regulatory requirements
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams
• Be flexible to adapt and accommodate additional duties as assigned

And will also include
:

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives and impact on Olema’s programs
• Lead the global regulatory team(s) and ensure execution of the Regulatory strategies to achieve the company objectives
• Mentor and develop other regulatory colleagues in the department
• Support SVP Regulatory Affairs, as required

Ideal Candidate Profile >>>
Innovative Experienced Regulatory Strategy Leader

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

• Bachelor’s degree in a scientific discipline
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred

Experience

• At least 12 years’ experience in Regulatory Affairs in Pharma/Biotech
• Minimum of 3 years direct leadership…