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About the Role

The Associate Director, Global Regulatory Affairs, Compliance will play a key role in advancing Olema’s development programs and helping bring innovative therapies to patients. This role involves partnering cross-functionally to develop and execute regulatory strategies towards compliance that support the company’s business objectives while ensuring compliance with applicable laws, regulations, and guidance.

Responsibilities

Translate applicable laws, regulations, and guidance into practical regulatory strategies supporting compliance that support development programs and business objectives.
Support the high-quality, timely execution of regulatory activities, deliverables, and milestones.
Author and contribute to compliance of regulatory submission documents, including INDs, NDAs, health authority meeting materials, and related correspondence.
Review regulatory submissions for accuracy, consistency, completeness, and compliance.
Develop and enhance regulatory policies, procedures, and SOPs that support effective and compliant operations.
Provide regulatory expertise and documentation support during regulatory and quality inspections.
Maintain current knowledge of pharmaceutical development concepts, practices, and regulatory requirements, including applicable provisions of 21 CFR Parts 50, 54, 56, 200, 201, 202, 207, 312, and 314, as well as relevant ICH guidelines.

Requirements

Bachelor’s degree in a scientific or related discipline; an advanced degree is preferred.
8+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
Demonstrated ability to interpret and apply applicable laws, regulations, and regulatory guidance.
Required experience in technical and regulatory writing.
Proven ability to independently plan, prioritize, and accomplish goals using sound judgment.
Detail-oriented and highly organized, with the ability to manage multiple priorities and deadlines.
Flexible and adaptable, with the ability to thrive in a dynamic, fast-paced environment.
Strong interpersonal skills and the ability to collaborate effectively across functions.
Sound professional judgment when interacting with external experts, health authorities, and other key stakeholders.
Excellent written and verbal communication skills.
Strong organizational, project management, and problem-solving skills.
Excellent oral, written, and presentation skills.
Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities.
Self-starter with the ability to work both independently and within teams.

Skills

Technical writing
Regulatory writing
Project management
Problem-solving
Communication

Location

Cambridge, MA
San Francisco, CA

Work Type

Onsite (at least two days per week)
Hybrid

Experience Level

Associate Director
8+ years

Education Level

Bachelor's degree in a scientific or related discipline
Advanced degree preferred

Salary/Compensations

$190,000-$210,000 annually

Benefits

Equity
Bonus
Benefits package
Open, flexible, and friendly work environment

About the Company

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond.
Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials.
Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant.
Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer.
We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution.
Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day.

Equal Opportunity

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.