Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Olema Oncology•Boston, MA

3d•$275,000 - $290,000•Onsite

About The Position

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 >>> 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.

Requirements

Bachelor’s degree in a scientific discipline
Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred
Minimum of 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 is strongly preferred
Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
Experience with major regulatory submissions (e.g. New Drug Applications (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 is required
Ability to work in a fast-paced environment in a hands-on fashion
Excellent oral, written, and presentation skills, with experience presenting to the leadership teams
Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams
Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines
Demonstrated ability to analyze and interpret efficacy and safety data
Strong understanding of regulatory operational activities
Self-starter
Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities
Team Player
On site presence at the headquarter is required (minimum 2 days a week)

Nice To Haves

Experience in all phases of development and post marketing activities is highly preferred

Responsibilities

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.)
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
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

Benefits

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.

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