Sr. Manager, Regulatory Operations

About Alterome:

Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a team of experienced leaders with a history of developing marketed oncology small molecule drugs. Alterome recently secured $132 million in Series B funding.

Job Summary:

Alterome is seeking an experienced Sr. Manager of Regulatory Operations to play a critical role in coordinating and managing regulatory activities to support global drug development programs. This position requires a detail-oriented professional with strong project management skills and regulatory expertise to ensure compliance with regulatory requirements and successful execution of regulatory strategies.

How You’ll Contribute to the Team…

• Manage the coordination and review regulatory submissions (INDs, CTAs, NDAs, MAAs, supplemental applications, etc.), in collaboration with the regulatory lead and cross-functional teams.
• Develop and maintain regulatory documents, such as cover letters, FDA forms, administrative information, and letters of authorization, for submission to regulatory agencies.
• Support regulatory meeting preparation, including scheduling meetings, preparing agendas, tracking action items, and coordinating responses to regulatory inquiries.
• Maintain regulatory tracking systems, including health authority query (HAQ) trackers, and archive regulatory correspondences in compliance with internal standards.
• Collaborate with cross-functional teams, including CMC, Translational, Clinical, Quality, and Program Management, to ensure accurate and timely execution of regulatory plans.
• Participate in internal and external project team meetings, prepare meeting materials, and document meeting minutes to facilitate project progress and decision-making.
• Stay updated on relevant regulatory guidelines, industry trends, and best practices to contribute to continuous process improvement within the regulatory affairs function.
• Participates in the writing of regulatory processes (SOPs, work instructions, and/or internal guidelines) and other departmental initiatives to improve standards and systems internally.

Required Qualifications:

• BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered.

• 8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations.

• Minimum of 5 years in regulatory affairs or regulatory operations experience.

• Knowledge of global regulatory requirements, including FDA (CDER), EMA, MHRA, and other major regulatory authorities.

• Highly organized, detail-oriented, and capable of managing multiple projects and priorities simultaneously.

• A collaborative mindset with the ability to work effectively in a cross-functional, fast-paced environment.

Who are Alterome Employees?

Although we share varied backgrounds and come with expertise in different areas, we aim to inspire hope for those affected by cancer. Our vision unites us to develop unique therapies that transform the lives of cancer patients, one alteration at a time. Thus, we seek the best people to join this special movement and invest the resources they need to grow, develop, and accomplish our collective goals. We have a passion for what we do and truly enjoy working with each other. In fact, many of us have worked together in multiple companies and there is a genuine camaraderie amongst the group. We would love to bring new faces to the group, and that’s where you come in!

Alterome Offers:

We provide our employees with medical, dental, and vision coverage, life insurance, a 401k w/company matching, competitive compensation (including equity), paid holidays, flexible time off, home office set up, full-service gym on-site (with showers and towel service!), professional development opportunities, phenomenal company culture, and more! Our office is centrally located in San Diego, CA at the intersection of the 15 and 56 Freeways. This is a hybrid role with three days per week in the office required - out of state candidates will not be considered at this time.

Salary Range:  $145,000 - $185,000/year based on skills and experience.

EEOC Statement:

Alterome Therapeutics, Inc. is an equal opportunity employer committed to building a diverse and inclusive organization. We measure each applicant, candidate, and employee based on their qualifications for the role, regardless of age, sex, religion, sexual orientation, gender identity, national origin, Veteran status, disability, and/or any other protected class characteristics. Furthermore, Alterome is committed to achieving all business objectives in compliance with all federal, state, and local laws.