Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Overview

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs at Olema Oncology. Reports to the Senior Vice President of Regulatory Affairs.

Location:

Boston, MA or San Francisco, CA. Domestic and international travel up to 20%.

• 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 regulatory requirements
• Coordinate and maintain all HA reporting schedules in collaboration with 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

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. 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 preferred)

Experience

• At least 12 years’ experience in Regulatory Affairs in Pharma/Biotech
• Minimum of 3 years direct leadership experience
• Experience with development and execution of regulatory strategies in Oncology Therapeutic area preferred
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
• Experience with major regulatory submissions (NDA/NDS/MAA) is a must
• Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product
• Ability to work in a fast-paced environment in a hands-on fashion
• Excellent oral, written, and presentation skills, with experience presenting to leadership teams
• Demonstrated proficiency in organizational awareness and cross-functional collaboration on global teams
• Excellent…