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What is the role of a Director, Regulatory Affairs CMC at Jobgether?

The Director, Regulatory Affairs CMC position at Jobgether is a Full-time or part-time position opportunity in the Information Technology field.

Where is this Director, Regulatory Affairs CMC job located?

United States, Other / Non-US, United States

What type of employment is offered for this Director, Regulatory Affairs CMC role?

Full-time or part-time position

What is the expected salary for this Director, Regulatory Affairs CMC job?

Compensation will be discussed during the hiring process.

Director, Regulatory Affairs CMC job near me in United States, Other / Non-US at Jobgether

Director, Regulatory Affairs CMC

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Regulatory Affairs CMC in United States.

This is a senior-level regulatory leadership role focused on driving global Chemistry, Manufacturing, and Controls (CMC) strategy across complex biopharmaceutical development programs. The position plays a critical role in ensuring regulatory excellence from early development through commercialization and post-approval lifecycle management. Operating in a fast-paced, highly collaborative biotech environment, the role requires deep expertise in global regulatory frameworks and the ability to influence cross-functional teams spanning Manufacturing, Quality, Clinical Operations, and Program Management. The Director will act as a key strategic partner, shaping regulatory pathways that enable timely clinical progression, successful submissions, and compliant product launches. This is a high-impact opportunity to directly contribute to the advancement of innovative therapies and global patient access.

Accountabilities:

Lead the development and execution of global CMC regulatory strategies across all stages of product development, including IND, IMPD, BLA/MAA, and post-approval activities.
Oversee preparation, quality, and delivery of CMC sections for global regulatory submissions, including responses to Health Authority questions and queries.
Provide strategic regulatory guidance to Manufacturing and Quality teams to ensure compliance, inspection readiness, and alignment with global requirements.
Manage regulatory aspects of manufacturing changes, product lifecycle updates, and global change control processes.
Coordinate and support global regulatory submissions, maintaining alignment with regional requirements and evolving regulatory expectations.
Partner closely with cross-functional teams to ensure successful delivery of key regulatory milestones across development and commercialization programs.
Identify regulatory risks proactively and develop mitigation strategies to support program timelines and success.
Contribute to internal regulatory knowledge sharing by capturing best practices, insights, and lessons learned across programs.

Requirements:

Bachelor’s degree in Life Sciences or related scientific discipline required; advanced degree (MS or PhD) strongly preferred.
10+ years of experience in biotechnology or pharmaceutical industry, including at least 7+ years in Regulatory Affairs with strong CMC focus.
Proven experience leading CMC components of global regulatory submissions, including BLA/MAA filings.
Strong experience interacting with global Health Authorities (FDA, EMA, and other international agencies).
Deep understanding of CMC regulatory requirements across clinical development, commercialization, and lifecycle management.
Strong knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks.
Extensive experience with CTD structure and global submission requirements.
Ability to independently manage multiple complex regulatory programs in a fast-paced environment.
Strong strategic thinking, problem-solving, and ability to balance scientific, operational, and regulatory priorities.
Excellent written and verbal communication skills, including regulatory writing and executive-level stakeholder engagement.
Demonstrated ability to influence cross-functional teams and senior leadership without direct authority.
High attention to detail with a strong commitment to quality, compliance, and regulatory rigor.
Ability to work autonomously, meet strict deadlines, and adapt to evolving priorities.
Recent, hands-on experience in CMC regulatory activities within a regulated life sciences environment is essential.

Benefits:

12-month full-time contractor engagement with potential for extension based on performance and business needs.
Competitive contract structure aligned with senior regulatory leadership roles.
Primarily remote work model with EST hours alignment.
Occasional on-site collaboration opportunities in Waltham, MA.
Exposure to global regulatory programs and high-impact biopharmaceutical development projects.
Opportunity to influence strategic regulatory pathways for innovative therapies.
Collaborative, cross-functional working environment with senior scientific and operational leaders.
Potential travel for key project phases and stakeholder engagement.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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Director, Regulatory Affairs CMC in United States at Jobgether

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