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Director of Regulatory Affairs
A company is looking for a Director of Regulatory Affairs. Key Responsibilities Develop and implement regulatory strategies for submissions and identify regulatory risks Provide guidance for product development projects and review documents for submission-readiness Lead regulatory discussions with health authorities to facilitate submission approvals Qualifications Minimum 10 years' experience with a BS degree, 8 years with an MS degree, or 6 years with a PhD in the pharmaceutical/biotech industry Advanced degree preferred; experience with biologics is a plus Strong knowledge of current US CMC regulations and CTD format Hands-on experience in managing regulatory applications, including US IND or CTA submissions In-depth knowledge of global regulatory requirements for drug development and approval
A company is looking for a Director of Regulatory Affairs.
Key Responsibilities
Develop and implement regulatory strategies for submissions and identify regulatory risks
Provide guidance for product development projects and review documents for submission-readiness
Lead regulatory discussions with health authorities to facilitate submission approvals
Qualifications
Minimum 10 years' experience with a BS degree, 8 years with an MS degree, or 6 years with a PhD in the pharmaceutical/biotech industry
Advanced degree preferred; experience with biologics is a plus
Strong knowledge of current US CMC regulations and CTD format
Hands-on experience in managing regulatory applications, including US IND or CTA submissions
In-depth knowledge of global regulatory requirements for drug development and approval