Associate Director, Global Regulatory Affairs Compliance

Olema Oncology; Boston (MA); On-site; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits package

Job summary

Olema Oncology in Cambridge, MA or San Francisco, CA is seeking an Associate Director, Global Regulatory Affairs, Compliance to lead regulatory strategies, ensure compliance across programs, and coordinate with cross-functional teams to advance palazestrant and OP-3136 through INDs and NDAs.

You will craft high-quality submissions, maintain knowledge of 21 CFR parts and ICH guidelines, supervise writing, and support inspections; this hybrid role requires onsite presence two days per week and

Qualifications

• Bachelor’s degree in a scientific or related discipline (required).
• Advanced degree is preferred.
• Proven ability to interpret and apply applicable laws, regulations, and regulatory guidance.
• Required experience in technical and regulatory writing.
• Strong planning, prioritization, and judgment skills.
• Detail-oriented and highly organized with the ability to manage multiple priorities.
• Flexible and adaptable in a fast-paced environment.
• Strong interpersonal and cross-functional collaboration skills.
• Excellent written and verbal communication skills.

Responsibilities

• Translate applicable laws, regulations, and guidance into regulatory strategies supporting development programs and business objectives.
• Supporting high-quality, timely execution of regulatory activities, deliverables, and milestones.
• Author and contribute to 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 and regulatory requirements, including 21 CFR Parts 50, 54, 56, 200, 201, 202, 207, 312, and 314, as well as relevant ICH guidelines.

Skills

Regulatory affairs

Technical writing

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Communication skills

Project management

Attention to detail

Leadership

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Job description

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. It’s an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon.

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. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity.

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. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC.

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.

If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – forour patients, for your career, and for what’s beyond.

About the Role

Associate Director, Global Regulatory Affairs, Compliance

As the Global Associate Director, Regulatory Affairs Compliance, reporting to the Senior Director, Global Regulatory Strategy, you will play a key role in advancing Olema’s development programs and helping bring innovative therapies to patients. You will partner 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.

You will support the management and compliance of high-quality regulatory submissions—including INDs, NDAs, health authority meeting materials, and other key documents—and contribute to the regulatory and technical writing required throughout the product development lifecycle.

This position is based in our Cambridge, MA, or San Francisco, CA office, with an expectation of being onsite at least two days per week. The role requires approximately 10% travel.

Your work will primarily encompass:

• Translate applicable laws, regulations, and guidance into practical regulatory strategies supporting compliance that support development programs and business objectives
• Supporting 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

Ideal Candidate Profile Regulatory Affairs Compliance

Experience:

• 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

Attributes:

• 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

The base pay range for this position is expected to be $190,000 - $210,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

Important Information

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.

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.

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.