Minimum of 15 years in pharma/biotech drug development.
At least 5 years in global CMC regulatory affairs.
5+ years of experience with small molecules and new chemical entities (NCEs).
Experience with global submissions including IND, IMPD, CTA, NDA, and MAA.
Background in oncology and product commercialization for small molecules.
Responsibilities
Lead the development and execution of global CMC regulatory strategies.
Prepare, review, and maintain global CMC dossiers throughout all development stages.
Engage in CMC-related interactions with health authorities.
Drive submission delivery for clinical trial applications and marketing authorizations.
Support lifecycle management for products in clinical development.
Benefits
Opportunity to lead strategic initiatives in a pivotal role.
Engagement with global health authorities.
Involvement in the commercialization of innovative oncology products.
Collaboration with cross-functional teams in a dynamic environment.
Full Job Description
Description
Director, CMC Regulatory Affairs
The Role:
You will be responsible for developing, driving , and executing CMC Regulatory strategies for products in clinical development and marketing authorization for small molecules. Strategic leadership and hands on submission delivery to support global clinical trial applications, registration, commercial readiness, and lifecycle managment is the key.
Key Responsibilities:
Will be the CMC Regulatory program lead to develop and execute global CMC regulatory strategies.
Prepare, review and maintain global CMC dossiers across all development stages.
Participate in CMC-related HA interactions.
Experience/Education:
MS or PhD in a scientific field with a minimum of 15 years of experience in pharma/biotech drug development, including a minimum of 5 years of global CMC regulatory affairs experience.
Must have 5+ years of small molecule experience. Experience with NCEs.
Experience with global submissions (IND, IMPD, CTA, NDA, MAA, post-approval).
Experience in oncology and product commercialization for small molecules.
