Reports To:  
Vice President, Regulatory Affairs

Basic Function:
The Director of Regulatory Affairs is responsible for expediting new product filings and registrations and ensuring adequate product filing/registration maintenance under the direction of the Vice President of Regulatory Affairs.

Education/Work Experience:
* Bachelors or advanced degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering or equivalent.
* More than 5 years healthcare experience.
* Direct Regulatory Affairs submission experience (ANDA and eCTD) preferable.

Principal Accountabilities:
* Project manage the global regulatory aspects to ensure all deliverables are completed on time.
* Develop effective and proactive regulatory strategies for CMC global product development and life cycle management.
* Establish regulatory strategies to provide critical support for product development and improvements and remediation of other product issues to obtain and maintain product approval.
* Provide interpretative analyses of complex regulatory guidance documents, regulations or directives
* Lead, assess, coach, and develop a Regulatory Affairs team and mange its performance.
* Coordinate efforts to answer deficiency letters, including establishing regulatory strategies, advising on data requirements, and preparing responses.
* Review dossiers for FDA submission including ANDA’s, 505(b)(2)’s, DMF’s and 510(k)’s in line with regulatory requirements, regulatory guidelines, and GMP compliance. 
* Identify, assist with gathering, and evaluate data from partners as needed to support submissions.
* Review labeling, advertising, promotional materials, study protocols, validation protocols to ensure compliance with applicable regulations and existing regulatory filings.
* 10%-20% domestic and international travel.

Specific Technical/Job-Related Skills:
* Possess strong organizational skills for prioritizing workload and responsibilities.
* Strong written communication, interpersonal, negotiations and problem solving skills are required.
* Proficient with PC-based word processors, databases and spreadsheets.