Assistant Director/Director, Regulatory Affairs/Clinical Quality Assurance

Our client is a fast growing biopharmaceutical company focused on the commercialization of therapeutics related to respiratory, oncology and critical care.

 

Job Responsibilities:
Interpret regulations and assist in the development of regulatory strategy for assigned projects/products
Prepare regulatory submissions (IND, NDA) in support of assigned projects/products.
Serve as key contact with Regulatory Agencies and facilitate communications between project teams and Regulatory Agency personnel.
Review and approve amendments to clinical study documents; e.g. Informed Consent Form, Investigative Brochure, Protocols, etc.
Generate and obtain approval for investigational and commercial product labeling.
Review and approve product promotional material prior to distribution.
Assist in the selection and qualification of contractors who supply services in support of clinical development
Provide oversight of clinical development contractors, including routine audits
Assure implementation of appropriate quality systems in support of clinical development
Participate in investigations of clinical non-compliance and assure appropriate documentation and resolution of issues.

 

Job Requirements:
5+ years of Regulatory Affairs/Quality experience, with focus on pre- marketed development
Thorough knowledge of US and international regulatory requirements, with focus on clinical development
Direct interaction with FDA required; experience with international BOH desired
Graduate degree preferred, MS, PharmD. in related field

 

Compensation:  $137,000 (commensurate with experience)



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