Senior Manager, Regulatory Affairs

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.

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.

KEY RESPONSIBILITIES

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

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

May supervise employees and consultants/contractors in Regulatory Affairs

Develop and implement regulatory operating guidelines and common work practices/strategies within the team

QUALIFICATIONS

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

PAY RANGE

The salary range for this role is $180,000 - $195,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.

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.