Job Description
Position Overview
Reporting to the Vice President, Regulatory Affairs, the Senior Director, Drug Regulatory Affairs provides regulatory expertise and leadership to assure the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. This position is responsible for developing global regulatory strategies, overseeing the filing of necessary applications, leading and positively impacting government interactions pertaining to the regulation process for products requiring governmental approval and for managing the staff associated with these activities
Reporting to the Vice President, Regulatory Affairs, the Senior Director, Drug Regulatory Affairs provides regulatory expertise and leadership to assure the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. This position is responsible for developing global regulatory strategies, overseeing the filing of necessary applications, leading and positively impacting government interactions pertaining to the regulation process for products requiring governmental approval and for managing the staff associated with these activities
Desired Skills & Experience
Position Requirements
Candidate must have knowledge in a variety of pharmaceutical concepts, practices, and procedures, and is familiar with ex-US advice and registration procedures. Must have strategic expertise in interpreting applicable laws and excellent interpersonal, as well as professional communication and negotiation skills. Ability to interact with, and persuade internal partners and regulatory agencies is require, and candidate must also be able to apply complex science to program and developmental needs
Candidate must have knowledge in a variety of pharmaceutical concepts, practices, and procedures, and is familiar with ex-US advice and registration procedures. Must have strategic expertise in interpreting applicable laws and excellent interpersonal, as well as professional communication and negotiation skills. Ability to interact with, and persuade internal partners and regulatory agencies is require, and candidate must also be able to apply complex science to program and developmental needs
Education and Experience
Must have a PhD, MD, PharmD or equivalent degree(s) in a scientific discipline, and 10-15 years of global drug regulatory affairs experience
Additional Requirements
Candidate should be able to work core hours in New Jersey with occasional travel, both in the US and ex-
Candidate should be able to work core hours in New Jersey with occasional travel, both in the US and ex-
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Email: jobs@aarenconsultants.in Resume or CV with Job Post Title
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