New · posted Oct 15
Marea Therapeutics · Biotechnology
Senior Manager, Regulatory Affairs
- South San Francisco, CA
- Hybrid
- Full-time
- Manager
Open until filled
The role
Reporting to the Director, Regulatory Affairs, the Senior Manager, Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies.
This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.
Relationships
- Build and maintain collaborative relationships with external business partners to achieve project regulatory goals
- Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
- Develop and manage relationships with external vendors and regulatory health authorities
- Manage activities for meetings and conferences with FDA, EMA, and other regulatory authorities
Management
- May supervise employees and consultants/contractors in Regulatory Affairs
- Develop and implement regulatory operating guidelines and common work practices/strategies within the team
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.
What you need
- Bachelor’s degree is required, preferably in a scientific field; advanced degree is a plus
- 8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry strongly preferred; experience in cardiometabolic/cardiovascular or endocrinology therapeutic areas is a plus
- Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
- Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
- Solid working knowledge of core processes: discovery, development, and manufacturing
- Experience with eCTD requirements and electronic submissions
- Experience with international regulatory submissions and processes is a strong plus
- Ability to work effectively across teams, functions and with outside partners
- Excellent oral and written communication skills
- Excellent organizational skills and attention to detail
What you'll do
- Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence
- Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks
- Manage coordination, preparation, and timely submission of regulatory documents and filings
- Review global regulatory submissions for consistency and quality across regions
- Manage preparation of responses to queries from regulatory authorities
- Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
- Ensure conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programs
- Provide regulatory advice to other functional areas
- Participate in regulatory due diligence activities
Pay
$180,000 – $195,000 a year
Employer providedIn compliance with applicable pay transparency laws, the expected base salary range for this position is $180,000 to $195,000 annually. This range represents the Company's good faith estimate of the salary range for this role at the date of hire and is subject to change.
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.
Where you'll work
South San Francisco, CAHybridOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAFrom the posting
About Marea Therapeutics
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 serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.
The company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 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 quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC nomination expected this year.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in California14 roles publishing pay
Manager roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $180,000 | — | $195,000 |
| California (middle half) | $159,000 | $171,000 | $179,500 |
| All US (middle half) | $146,750 | $162,500 | $177,750 |
This role: Marea Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Marea Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions7
- GMP and compliance2
- Documentation and SOPs1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
Company hiring pulse
Marea Therapeutics on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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Senior Manager, Regulatory Affairs at Marea Therapeutics
Open until filled. $180K–$195K a year, employer provided.