Associate Director/Director, Regulatory Affairs
ABOUT THE COMPANY
Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to complement existing therapies and serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.
Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well funded by a syndicate of leading life science investors including Sofinnova, Forbion, Xontogeny/ Perceptive Advisors, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures.
The company’s lead program, MAR001, is a monoclonal antibody targeting ANGPTL4, a genetically validated target with potential to address the subset of patients at the highest risk of adverse cardiovascular events, despite current standard of care therapies. MAR001 is rapidly progressing through Phase 2b clinical development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is rapidly progressing through Phase 1 clinical development. We also have a third asset that is rapidly advancing through research discovery, with DC nomination expected next year.
At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is “Hands-On”, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results.
ABOUT THE ROLE
We are seeking a strategic and hands-on Associate Director/Director, Regulatory Affairs to drive global regulatory strategy and execution for key development programs from preclinical stages through marketing approval. Reporting to the Executive Director, Regulatory Affairs, this individual will serve as a primary regulatory liaison and a core partner to cross-functional teams. This is a high-visibility role in a dynamic, small-company environment that offers the opportunity to "wear multiple hats" and play a pivotal role in shaping the future growth of the Regulatory department.
This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.
KEY RESPONSIBILITIES
- Develops and executes global regulatory strategy for development programs, ensuring alignment with corporate business objectives.
- Acts as the primary liaison between the company and global health authorities (FDA, EMA) for assigned projects, leading the preparation and conduct of agency meetings.
- Plans, coordinates, writes, and reviews regulatory documents (e.g., INDs/CTAs, IBs, Annual Reports, briefing packages) to ensure high quality and compliance.
- Manages external vendors and consultants, including CROs and eCTD publishers, to ensure timely and cost-effective execution of regulatory deliverables.
- Proactively identifies regulatory risks and provides mitigation strategies to cross-functional project teams, clinical strategy teams, and executive leadership.
- Provides regulatory guidance on clinical and nonclinical development to ensure alignment with health authority expectations.
- Monitors and analyzes the global regulatory environment, assessing the impact of new regulations on the company’s development programs.
- Works closely with the Executive Director, Regulatory Affairs to define and drive global regulatory strategy for company programs.
- Reviews and approves technical data, protocols, and reports to ensure suitability for regulatory filings.
QUALIFICATIONS
- Bachelor’s degree in life sciences or related field required; Advanced degree (Master’s, PharmD, PhD) strongly preferred.
- For Associate Director: Minimum 8+ years relevant industry experience with 5+ years in Regulatory Affairs.
- For Director: Minimum 10+ years relevant industry experience with 7+ years in Regulatory Affairs.
- Demonstrated experience independently managing regulatory submissions (IND/CTA) and interacting directly with health authorities. Experience with marketing applications (NDA/BLA/MAA) is a plus.
- Knowledge of eCTD publishing processes and experience working with external publishing vendors.
- Strong knowledge of GXP (GCP, GLP) and ICH guidelines.
- Ability to work in a fast-paced, small-company environment, manage ambiguity, and shift priorities easily.
- Ability to interpret complex regulatory guidelines and negotiate competitive regulatory strategies.
- Experience leading cross-functional teams without direct authority.
- Occasional travel (~10-15%) to company offices or for agency engagement.
PAY RANGE
The salary range for this role is $185,000 - $240,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.
WORKING CONDITIONS
- Prolonged periods of being at a stationary desk or working on a computer
- Assessing the accuracy, neatness, and/or thoroughness of the work assigned
- Communicating with others to exchange information
- Ability to travel as needed (up to 10%) for conferences, regulatory interactions, corporate and department-wide meetings/needs
#LI-Hybrid
We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.
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