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Director of Regulatory Affairs

Location: NJ/NY
Industry: Pharmaceutical/Biotechnology
Job Code: 12024-06

Requirements:

Detail-oriented with a strong background in CMC and biologics and a solid working knowledge of cGLPs and cGCPs. Experience in eCTD NDA/BLA requirements and post-marketing activities is required. Experience in antibodies is essential. The candidate is a proven leader with the ability to establish regulatory policies and strategies in full compliance with all applicable regulatory requirements. The Director, Regulatory Affairs has an integral part in the development of regulatory strategy and the successful execution of regulatory plans and initiatives for the Regulatory Affairs function for addressing complex and diverse submissions for assigned products and therapeutic areas, and addressing regulatory matters to ensure compliance with established regulatory and business requirements.

 

Qualifications:

• Must have at least 12+ years of Regulatory Affairs experience
• Experience in eCTD NDA/BLA requirements and post-marketing activities is required
• Requires a strong background in CMC and biologics and a solid working knowledge of cGLPs and cGCPs
• Must have prior management experience
• Experience in antibodies is essential

Contact:

For more information on this or any of our other available positions or to be contacted by one of our staffing specialists, please send us your resume, cover letter and RegExec job code to resume@regexec.com.

PLEASE NOTE: All resumes that are received by RegExec will be thoroughly reviewed by one of our staffing specialists and treated confidentially.