Global Regulatory Compliance Director (Associate)

Olema Pharmaceuticals, Inc.; Massachusetts; Hybrid; USD 190.000 - 210.000; Vollzeit

Zusammenfassung

Olema Pharmaceuticals, Inc. is seeking an Associate Director, Global Regulatory Affairs Compliance to lead regulatory strategies and writing across development programs.

You will partner with multiple functions to ensure compliant submissions and documentation throughout the product lifecycle. The role is based in Cambridge, MA or San Francisco, CA, onsite at least two days per week, with roughly 10% travel.

Qualifikationen

• Bachelor's degree in a scientific field; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Experience in technical and regulatory writing.
• Ability to plan, prioritize, and meet deadlines.
• Strong collaboration across functions.

Aufgaben

• Translate applicable laws into practical regulatory strategies supporting compliance and development goals.
• Support high-quality, timely execution of regulatory activities, deliverables, and milestones.
• Author and contribute to regulatory submission documents and related correspondence.
• Review regulatory submissions for accuracy, completeness, and compliance.
• Maintain current knowledge of regulatory requirements and ICH guidelines.

Kenntnisse

Regulatory strategy

Regulatory writing

Cross-functional collaboration

Regulatory interpretation

Attention to detail

Ausbildung

Bachelor's degree in science

Advanced degree preferred

Jobbeschreibung

Associate Director, Global Regulatory Affairs, Compliance and Project Management

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. With our transformation into a fully integrated oncology company well underway, it’s an exciting time to be part of Team Olema.

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 Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028. 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 could transform the metastatic breast cancer treatment paradigm and provide access to 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 presented encouraging Phase 1 monotherapy data from this program across multiple solid tumor types, are advancing patient enrollment in the ongoing combination arms in MBC, and expect to initiate a Phase 1 study of OP-3136 in combination with Bayer’s darolutamide in metastatic castration-resistant prostate cancer by the end of this year.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and passionate colleagues dedicated to helping the patients we serve feel better, longer. Team Olema possesses a deep commitment to a shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. We are a small group of nimble self-starters who bring consistency in our 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 – for our patients, for your career, and for what’s beyond.

About the Role >>> Associate Director, Global Regulatory Affairs, Compliance and Project Management

As the Global Associate Director, Regulatory Affairs, compliance and project management reporting to the Senior Director, Global Regulatory Strategy, you will play a key role in the managing projects designed towards advancing Olema’s development programs and helping bring innovative therapies to patients.The role involves oversight of all regulatory compliance activities.You will partner cross-functionally to manage the projects of all Olema assets in development and post approval. Implementstrategiesto ensure compliance with applicable laws, regulations, and guidance documentsforregulatory submissions and regulatory operational activities.

You will support managing all projects with adherence to 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. The role requires approximately 10% travel.

Your work will primarily encompass:

• Translate applicable laws, regulations, and guidance for managing regulatory projects.
• Implement regulatory strategies supporting compliance that support development programs and business objectives.
• Supporting the high-quality, timely execution of regulatory activities, deliverables, and milestones.
• Interact with cross functional project teams tomanageand track all regulatory activities and communicate any identified risks to wards compliance of regulatory submission documents, including INDs, NDAs, health authority meeting materials, and related correspondence.
• Manage the timelines for all regulatory milestones across projects and support regulatory operations for tracking and maintaining submission timelines.
• Provide remedial actions to any identified risks across projects including any unforeseen situations that can delay or hinder project continuity
• 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 Compliance Project Management

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.

Experience:

• Bachelor’s degree in a scientific or related discipline; an advanced degree is preferred.
• 8+ years of RegulatoryCompliance and Project Management experience within the pharmaceutical or biotechnology industry.
• Demonstrated skills to interpret and apply applicable laws, regulations, and regulatory guidance to manage compliance.
• String interpersonal skills with the ability to work with cross functional project teams.
• 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 to thrive in a dynamic, fast-paced environment.
• Sound professional judgment when interacting with external experts, health authorities, and other key stakeholders.
• Project Management (PMP) Certification preferred.
• 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$185,000 - $205,000annually, 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.

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.

Fraud Alert : We are aware of employment scams where individuals pose as representatives of Olema Oncologyand make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com ; our careers page is olema.com/careers ; our LinkedIn page is linkedin.com/company/olema-oncology .Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront paymentsof any kind, and does not make job offers without an in-person interview.

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