Associate Director CMC Regulatory

A company is looking for an Associate Director, CMC Regulatory Strategy.

Key Responsibilities

Lead the planning, authoring, and review of regulatory submissions for various projects

Provide in-depth reviews of protocols, reports, and documents for CMC Development or Commercial teams

Manage preparation and submission of responses to regulatory agencies and ensure compliance with regulatory strategies

Required Qualifications, Training, and Education

BSc / BA with experience in regulatory CMC or related fields

Demonstrated knowledge of CMC regulatory and drug lifecycle regulations

Experience with electronic Common Technical Document CMC regulatory documents

Understanding of FDA, EMA, and ICH guidelines

Exceptional interpersonal skills and ability to influence functional practices