Olema Oncology · 6 days ago
Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
Boston, MA
Full-time
Hybrid
Director/Executive
$275K/yr - $290K/yr
12+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. The Senior Director, Global Regulatory Strategy Lead will lead the development of regulatory strategies and submissions for the company's product portfolio, while representing Regulatory Affairs on cross-functional teams and ensuring compliance with health authority regulations.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Hiring Manager
Michelle Knobel
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
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
Qualification
Required
Bachelor's degree in a scientific discipline
Minimum of 12 years' experience in Regulatory Affairs in Pharma/Biotech
Minimum of 3 years direct leadership experience
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
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)
Preferred
Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred
Experience with development and execution of regulatory strategies in Oncology Therapeutic area is strongly preferred
Experience in all phases of development and post marketing activities is highly preferred
Demonstrated ability to analyze and interpret efficacy and safety data
Benefits
Equity
Bonus
Benefits
Competitive compensation and benefits package
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2025-12-25
thefly.com
2025-12-11
Company data provided by crunchbase