New · posted Oct 15
Marea Therapeutics · Biotechnology
Senior Director, Regulatory CMC
- South San Francisco, CA
- Hybrid
- Full-time
- Director
Open until filled
The role
We are seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for the development of regulatory strategies and submissions related to the manufacturing of our products in the US and globally. The incumbent will be responsible for overseeing Regulatory CMC aspects of Marea’s product development, manufacturing, and eventual commercialization efforts.
The position requires a strong ability to both think strategically and manage hands on execution, working well independently and in collaboration with internal and external cross-functional teams. The position reports to the Executive Director, Regulatory Affairs and will be involved in the future development and growth of the Regulatory CMC function. The role will also serve as a member of the Tech Ops leadership team to keep CMC strategy aligned with the company's overall regulatory strategy, with a dotted-line reporting relationship to the CTO.
This is a full-time position, with a strong preference for candidates that can work on-site at least two days per week in the San Francisco-based office.
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
- 15+ years of pharmaceutical or biotech industry experience, at least 10 years of experience in CMC Regulatory Affairs for biologics
- Bachelor’s Degree in biochemistry, chemistry, biology, or related pharmaceutical fields; advanced degree preferred
- Direct CMC Regulatory Affairs experience supporting monoclonal antibody (mAb) development is required
- Direct experience leading CMC interactions with regulatory health authorities
- Demonstrated experience creating and submitting high quality CTA/IND and BLA/MAA filings for biologics
- Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations, and ICH, FDA and EMA guidelines for biologic products
- Experience with drug-device combination products and/or device constituent parts (e.g., pre-filled syringes, autoinjectors), including familiarity with 21 CFR Part 4 cGMP requirements, design control and human factors expectations, and EU drug-device combination requirements (e.g., MDR Article 117)
- Demonstrated ability to think creatively and strategically, to interpret regulatory guidance and regulations, and to assess regulatory CMC risks and likelihood of success of various strategies
- Ability to collaborate and lead cross-functionally and to develop strong relationships with partners both internally and externally
- Ability to lead and build high functioning teams
- Strong oral and written communication skills with the ability to lead and influence at all levels of the organization
- Exceptional time and project management skills, with the ability to execute plans under pressure in a small, fast-paced environment with tight deadlines.
- Ideal candidates will have pre-commercial through launch experience, within a small company environment.
What you'll do
- Provide regulatory CMC strategic leadership to support development of Marea’s programs
- Partner with key functional heads in Technical Operations (Process/Analytical/Formulation Development, Manufacturing, Quality and Supply Chain) and other cross-functional stakeholders to ensure alignment of regulatory strategies with manufacturing and development activities
- Support development of manufacturing and control strategies for development products, including assessing proposed manufacturing process and analytical method changes and provide strategic regulatory guidance on phase appropriate considerations and comparability needs
- Lead CMC regulatory strategy for drug-device combination products and device constituent parts, including future pre-filled syringes and autoinjectors, in coordination with Device Development, Drug Product Development and Quality
- Serve as the Regulatory Affairs representative on CMC teams and committees
- Lead communications with regulatory agencies related to CMC strategies and issues
- Manage and implement planning, authoring, and submission of high-quality CMC‑related briefing documents and CMC portions of regulatory applications in the US and globally
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines; identify regulatory risks
- Maintain CMC Regulatory document control system
- Monitor regulatory guidelines and trends related to CMC; interpret regulations and guidance to provide advice to company leadership and CMC teams
- Facilitate timely responses to information requests and questions from health authorities regarding CMC
- Proactively identify CMC regulatory risks and propose mitigations that help shape a balanced CMC strategy
- Build Regulatory CMC functional capabilities, including growing the future Regulatory CMC team
Pay
$260,000 – $295,000 a year
Employer providedIn compliance with applicable pay transparency laws, the expected base salary range for this position is $260,000 to $295,000 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.
Where you'll work
South San Francisco, CAHybridOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAWorking 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
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.
From 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 32% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in California5 roles publishing pay
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $260,000 | — | $295,000 |
| California (middle half) | $204,500 | $241,000 | $248,000 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Marea Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Marea Therapeutics's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Regulatory submissions8
- GMP and compliance5
- Documentation and SOPs3
- Lab testing and methods2
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.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
Company hiring pulse
Marea Therapeutics on Regulatory Jobs
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- Open roles
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- Distinct roles
- 1
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Senior Director, Regulatory CMC at Marea Therapeutics
Open until filled. $260K–$295K a year, employer provided.