Associate Director Regulatory CMC

Barrington James; United States; On-site; USD 132,000 - 303,000; Full time

Job summary

A leading pharmaceutical company is seeking an Associate Director of Regulatory Affairs CMC to oversee regulatory strategies and compliance for their innovative products. This key role involves collaboration with multiple departments to ensure successful product approvals and requires extensive experience in regulatory submissions both in the US and globally.

Qualifications

• 12+ years of biotech/pharma experience, including 7+ years in Regulatory Affairs.
• Experience with US and international regulatory submissions.
• Strong understanding of biotech R&D and CMC requirements.

Responsibilities

• Define and execute global regulatory strategies for product development.
• Prepare and review regulatory submissions ensuring compliance.
• Collaborate with cross-functional teams to manage regulatory affairs.

Skills

Leadership

Collaboration

Project Management

Education

Bachelor's degree in a scientific field

Job description

Direct message the job poster from Barrington James

Regulatory Affairs, Quality Assurance and CMC - Barrington James Life Science Recruitment US Team

Associate Director Regulatory Affairs CMC

I am partnered with a small US pharmaceutical company who have commercial products on the US and Global Markets as well as new indications in development and they are currently seeking an Associate Director of Regulatory Affairs CMC to join their Regulatory Group.

Brief Responsibilities:

• Partners with CMC, Quality, Supply Chain, and Regulatory Affairs teams to define and execute global regulatory strategies for product development and approval.
• Advises on regulatory issues for development and post-marketing submissions, including global impact assessments for change controls and deviations.
• Collaborates with SVP of Regulatory Affairs to develop CMC regulatory strategies, identifying regional differences, key data needs, and core messaging.
• Leads CMC submission strategy for project teams, providing authorship and content review to ensure compliance with global standards and submission timelines.
• Prepares and/or reviews global regulatory submissions (INDs, NDAs, etc.), ensuring completeness, consistency, and regulatory compliance; maintains a risk register to track and resolve gaps ahead of submission.
• Bachelor’s degree in a scientific field (e.g., Chemistry, Biology, Microbiology) or equivalent required.
• Minimum 12 years of biotech/pharma industry experience, including 7+ years in Regulatory Affairs with focus on drug substance/drug product across development stages.
• Experience in the preparation, assessment, and submission of regulatory filings across phases of development with demonstrated knowledge and experience in US and European and/or Canadian and/or Japanese submissions
• Proven leadership, collaboration, and project management skills; thrives in fast-paced, multitasking environments.
• In-depth knowledge of biotech R&D and global regulatory CMC requirements.
• Strong track record in authoring and preparing global regulatory submissions.
• Experienced in developing and executing global regulatory strategies, with attention to regional differences across pre- and post-approval phases.
• Preferred experience in preparing briefing documents and leading global health authority meetings.

Notes:

• Sponsorship is not available for this role
• Candidate who live the following states cannot be considered due to Tax Implications - Maryland, Utah, Indiana, Texas, Georgia, Mississippi and California

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science and Strategy/Planning

• Industries

  Pharmaceutical Manufacturing

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