Senior Manager, Regulatory CMC Lead
1 week ago
Company Overview: Vera Therapeutics is a late-stage biotechnology company dedicated to developing treatments for serious immunological diseases. Our mission is to advance innovative therapies that target the root causes of these conditions, ultimately changing the standard of care for patients. With a focus on immunologic diseases, we are committed to making a meaningful impact on people's lives.
Salary: The anticipated base pay range for this role begins at $175,000. In addition to competitive base pay, you will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Your total compensation package will reflect your qualifications, skills, and experience.
Job Description: We are seeking a seasoned Senior Manager, Regulatory CMC to join our experienced team. As a key member of our regulatory affairs department, you will work closely with cross-functional teams to lead and support regulatory submissions and activities in the US and globally. This role requires strong expertise in both clinical and CMC aspects of product development, ensuring high-quality regulatory content that meets current regional requirements.
Responsibilities: Key responsibilities include:
• Proactively managing clinical and CMC aspects of products in early-to-late development.
• Authoring and reviewing clinical and CMC modules of applications and amendments for submission, guaranteeing complete regulatory content that meets regional standards.
• Representing regulatory affairs (clinical and CMC) on cross-functional project teams.
• Evaluating proposed manufacturing changes for their impact on existing filings and providing strategic regulatory guidance for optimal implementation.
Required Skills and Qualifications: To excel in this role, you must possess:
• A Bachelor's degree in a scientific field and 6+ years of relevant experience, with demonstrated regulatory affairs expertise commensurate with the position.
• Strong knowledge and experience in interpreting regulatory requirements, with a particular emphasis on the US region.
• Excellent written and verbal communication skills, as well as the ability to collaborate across functions.
• Industry experience in CMC development of biologics is highly preferred.
Benefits: At Vera Therapeutics, we strive to provide employees with a comprehensive compensation package. In addition to competitive base pay, you will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. You will also have access to various benefits offerings, including medical, dental, and vision insurance, 401k match, flexible time off, and paid holidays.
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