Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About 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.

Responsibilities

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

Requirements

15+ years of pharmaceutical or biotech industry experience, at least 10 years of experience in CMC Regulatory Affairs for biologics
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.

Skills

CMC Regulatory Affairs
Biologics Development
Monoclonal Antibody (mAb) Development
Regulatory Health Authority Interactions
CTA/IND and BLA/MAA Filings
Good Manufacturing Practices (GMP)
Drug and Biologics Development Regulations
ICH, FDA and EMA Guidelines
Drug-Device Combination Products
Device Constituent Parts
21 CFR Part 4 cGMP Requirements
Design Control
Human Factors
EU Drug-Device Combination Requirements
Strategic Thinking
Regulatory Risk Assessment
Cross-functional Collaboration
Team Leadership
Oral and Written Communication
Time Management
Project Management

Location

San Francisco

Work Type

Full-time
Hybrid

Experience Level

Senior Director
15+ years of pharmaceutical or biotech industry experience
10+ years of experience in CMC Regulatory Affairs for biologics

Education Level

Bachelor’s Degree in biochemistry, chemistry, biology, or related pharmaceutical fields
Advanced degree preferred

Salary/Compensations

$260,000-$295,000

Benefits

Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.

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 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.
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.

Equal Opportunity

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.