Associate Director Regulatory CMC
Virtual Vocations Inc, New York, NY, United States
A company is looking for an Associate Director, Regulatory CMC.
Key Responsibilities
Lead the planning, authoring, and approval of regulatory submissions for CMC sections Provide in-depth reviews of protocols and documents for CMC Development or Commercial teams Manage the preparation and submission of responses to regulatory agencies
Required Qualifications
BSc/BA with a minimum of eight years of regulatory CMC or related experience Demonstrated understanding of drug lifecycle regulations and guidelines Experience with electronic Common Technical Document CMC regulatory documents Knowledge of FDA, EMA, and ICH guidelines Ability to influence and work within multi-disciplinary teams and with external partners
Lead the planning, authoring, and approval of regulatory submissions for CMC sections Provide in-depth reviews of protocols and documents for CMC Development or Commercial teams Manage the preparation and submission of responses to regulatory agencies
Required Qualifications
BSc/BA with a minimum of eight years of regulatory CMC or related experience Demonstrated understanding of drug lifecycle regulations and guidelines Experience with electronic Common Technical Document CMC regulatory documents Knowledge of FDA, EMA, and ICH guidelines Ability to influence and work within multi-disciplinary teams and with external partners