Associate Director, Global Regulatory Affairs Compliance

Olema Pharmaceuticals, Inc.; San Francisco (CA); Hybrid; USD 190,000 - 210,000; Full time

Job summary

Olema Oncology seeks an Associate Director, Global Regulatory Affairs Compliance to advance development programs and ensure regulatory compliance across ind/submissions. Based in Cambridge, MA or San Francisco, CA, the role requires onsite presence and light travel.

Responsibilities include drafting and reviewing submissions, guiding regulatory strategy, and maintaining knowledge of 21 CFR parts and ICH guidelines. Collaboration with multiple functions is essential for success.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Experience in technical and regulatory writing.

Responsibilities

• Translate laws and guidance into regulatory strategies for compliance.
• Support timely execution of regulatory activities and milestones.
• Author regulatory submission documents and related correspondence.
• Review submissions for accuracy, completeness, and compliance.
• Develop and enhance regulatory policies, SOPs, and procedures.
• Provide support during regulatory and quality inspections.
• Maintain current knowledge of relevant regulations and ICH guidelines.

Skills

Regulatory strategy

Regulatory writing

Cross-functional collaboration

Regulatory submissions

Communication (written and verbal)

Regulatory inspections

Attention to detail

Education

Bachelor’s degree in science or related field

Advanced degree preferred

Job description

Associate Director, Global Regulatory Affairs Compliance

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 transfor mation into a fully integrated oncology company well underway , t op-line data from our lead program expected later this year , and our first potential commercial launch on the horizon.

Our leadproduct candidate,palazestrant, isa novel, orallyavailablecomplete estrogen receptor antagonist (CERAN)and selective estrogen receptor degrader (SERD)currently intwopivotalPhase 3clinicaltrials.We expect top-line data from OPERA-01,ourongoingPhase 3 trial ofpalazestrantas a monotherapy in patients withsecond- or third-lineER+/HER2-metastatic breast cancer (MBC), in the fallwhich, if successful, could lead to our first potentialapproval andcommercial launchin 2027. OPERA-02,ourPhase 3 trial ofpalazestrantin combination withribociblibin patients with frontlineER+/HER2- MBC, isenrolling patients.Togetherwith itsmechanism of action, pharmacokinetic properties,andthe potential todemonstrateactivity in bothESR1wild-type and mutant tumors,palazestranthas the potential totransform the metastatic breast cancer treatment paradigm andaccessa$15 billionglobal market opportunity.

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor withthepotential to generate further value and meaningfullyimpactthemetastatic breastcancertreatment landscape – particularly in combination withpalazestrant.We recently reportedencouragingPhase 1monotherapydata from this programacross multiple solid tumor types andareadvancingpatientenrollment in theongoingcombinationarmsin MBC.

Aspiring to transform the metastatic treatment paradigmis an ambitious endeavor that requires aresolute approach todeveloping better therapies and apassionateteamdedicated tohelping the patients we serve feelbetter,longer.Wepossessadeepcommitment toour shared purpose,thesustained pursuit of excellence, cultivatingthecouragerequiredto 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.

Ifyou’rereadyto bepartof atenacious,courageous,agile, andgrowingteam,join us in makinga profound impact,together– for our patients, for your career, and for what’s beyond .

About the Role >>AssociateDirector,GlobalRegulatory 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 themanagementand complianceof high-quality regulatory submissions—including INDs, NDAs, health authority meeting materials, and other key documents—and contribute to the regulatory and technical writingrequiredthroughout 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

IdealCandidate Profile >>>Regulatory Affairs Compliance

A love of challenging, important work.We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. Allemployeeswithin our company play aunique andcrucial rolein our success, both inaccomplishingour mission and buildinga positivecompany culture. As such, we are looking forsomeone withthe right combination ofknowledge,experience, andattributes for this role.

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 prioritiesSelf-starter with the ability to work both independently and within teams

The base pay range for this position is expected to be$190,000 - $210,000annually, 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.

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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.