Senior Director, Regulatory Affairs

Shelby American, Inc. is looking for Senior Director, Regulatory Affairs in San Francisco, CA. This local job opportunity with ID 3101109251 is live since 2025-03-06 20:13:59. Marea Therapeutics is a clinical-stage biotechnology company based in 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 now well funded by a syndicate of life science investors including Sofinnova, Forbion, Perceptive Advisors, Xontogeny, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures. The company’s lead program is in Phase 2 clinical development (MAR001) and a second program is progressing towards clinical development in acromegaly. Marea is a fast-growing company looking for extraordinary individuals to join our team who want to make a difference in the lives of millions of people living with cardioendocrine diseases. The company is led by a dynamic team of scientists and company builders with deep knowledge and experience in cardioendocrine diseases, human genetics, and adipocyte biology. 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 Our team is growing and we’re looking for an experienced Senior Director of Regulatory Affairs to play a pivotal role in driving the development and implementation of regulatory strategies that meet global regulatory requirements and align with the company’s goals and business objectives. They will serve as the main point of contact for all regulatory operations and submissions while collaborating with cross-functional teams internally and externally. This is a FTE position with a preference for candidates that can regularly work in the San Francisco-based office. Job Responsibilities Drive cross-functional teams to develop and implement creative long-range regulatory strategies that meet global regulatory requirements and include alignment with leadership and corporate goals. Provide ongoing oversight and guidance of global regulatory activities, and related risk assessments and mitigation strategies. Oversee and drive regulatory operations, lead global regulatory submissions INDs/CTAs and NDAs/BLAs, and manage correspondence with agencies like the FDA or EMA. Ensure timely and accurate submission of regulatory filings which includes clinical trial data, preclinical studies, and manufacturing process details. Oversee internal and external teams, vendors, consultants, and thought leaders to ensure appropriate strategies for, and progress of, regulatory activities. Develop, implement, and oversee stage-appropriate policies and procedures for regulatory activities and record keeping including document control ensuring all documents are well-organized, maintained, and readily accessible. Ensure the company is in compliance with regulatory standards (e.g. GCP, GMP, and GLP). Anticipate, identify, and assist in the resolution of risks, bottlenecks, and potential issues in regulatory-related activities. Continually assess and plan for appropriate resourcing to meet approved regulatory initiatives and stay current on evolving regulatory guidelines and industry best practices. Provide regular updates to cross-functional and leadership teams to ensure alignment, resourcing, and tracking. Qualifications Bachelor’s in related life science. 8-10 years in related positions in pharmaceuticals/biotechnology, with increasing responsibility that must include regulatory strategy and operations. Experience in cardiovascular, metabolic diseases, and/or rare diseases is a plus. Proven leadership of regulatory strategy and operations teams and vendors. Deep and facile understanding of the drug development and global regulations and guidelines, ideally encompassing preclinical through commercialization. Experience in supporting large, long-term studies and clinical development plans is a plus. Excellent communication, presentation, and interpersonal skills. Exceptional time and project management skills, with the ability to execute on plans under pressure in a small fast-paced environment with tight deadlines. High integrity and sense of urgency, with a desire to individually contribute and lead. Highly motivated, proactive, enthusiastic, and goal-oriented. The ability to anticipate potential pitfalls and proactively solve problems. The ability to work independently as well as coordinate and work with large cross-functional teams. Working Conditions Prolonged periods of being at a stationary desk or work computer. Ability to occasionally adjust, handle, or move objects up to [50] pounds. Assessing the accuracy, neatness, and/or thoroughness of the work assigned. Communicating with others to exchange information. Travel requirements as needed. Further information Annual Salary Range: $215,000-$285,000. The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary. In addition to a competitive compensation package, Marea also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, health spending account, life insurance, disability insurance, time off and a 401(k) plan. 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. #J-18808-Ljbffr Shelby American, Inc.