Manager, Regulatory Affairs CMC

Description

The Manager, Regulatory Affairs CMC is responsible for supporting and executing Regulatory CMC strategies in collaboration with cross-functional teams. This role manages CMC-related global regulatory submissions and Health Authority interactions to meet the project timelines for the assigned projects. This is a remote-based position located in the United States.

Responsibilities

• Support the development and implementation of Regulatory CMC strategies, including reviewing/authoring CTD CMC sections for assigned projects to ensure timely, high-quality global submissions for investigational, market, and post-approval applications.
• Assist in preparing responses to Health Authority CMC questions, pre-meeting packages, and interactions for assigned projects.
• Coordinate with the CMC team and other stakeholders to ensure timely submission of regulatory documents by tracking progress of document preparation.
• Collaborate with cross-functional teams, especially CMC and Quality groups, to assess regulatory impact on CMC-related issues.
• Contribute to regulatory risk assessment, identify key Regulatory CMC issues, and support mitigation activities throughout the product lifecycle.
• Participate in developing internal Regulatory CMC guidance and working instructions.
• Ensure proper Regulatory CMC assessment and actions are taken for recalls or product complaints during the product lifecycle.
• Provide Regulatory CMC review for clinical protocols and investigator brochures for assigned projects.

Requirements

• Bachelor’s degree in scientific disciplines required with expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.); MS/PhD is preferred.
• Minimum of 5 years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.
• Experience in leading the preparation of CMC modules to support CTA, NDA/MAA submissions, and subsequent responses to Health Authority queries.
• Expertise in ICH requirements and US/EU regulatory requirements.
• Experience with regulatory CMC requirements for EU markets and GMP regulation.
• Experience in authoring complex technical documents, CTD Module 2 and Module 3 sections, and lifecycle management.
• Experience with Veeva systems preferred.
• Excellent oral and written communication skills with strong attention to detail.
• Strong project management skills, including coordinating teams and managing timelines for regulatory submissions.
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable, collaborating effectively while working remotely, fostering ingenuity, and staying grounded in compassion.

The anticipated annual base salary range for this role is $125,000 to $160,000. Final compensation depends on multiple factors including but not limited to relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and a benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.

#LI-REMOTE

Apply here