Our client is looking for a Director, Regulatory Affairs.

JOB DESCRIPTION:
Responsible for the coordination, preparation and assessment of documents for regulatory submission from all areas of the company. Compile all materials required in submissions, license renewal and annual reports. Recommend strategies for earliest possible approvals of clinical trial applications. Identify issues that may increase regulatory risk, and propose strategies to address such risks. Responsible for managing, coaching, and developing Regulatory Affairs Associates and Specialists, as appropriate.

JOB DUTIES:
·Research and interpret relevant precedent and maintain files for regulatory development issues for related products
·Research, write, and edit various documents, as required, for internal use or submission to regulatory authorities
·Gather, review, assemble, and prepare appropriate documents for submission to outside regulatory agencies
·Accomplish IND/BLA/NDA filing processes in collaboration with a multi-disciplinary professional and support staff
·Monitor and improve tracking/control systems
·Assess labeling, marketing and clinical protocol for regulatory impact/issues
·Identify need for new SOPs and is responsible for their development
·Develop a regulatory strategy for IND/CTA and BLA/NDA filings in collaboration with project team and regulatory management
·Manage and develop Associates and Specialists, as appropriate ·Other duties as assigned

QUALIFICATIONS:
.BA/BS in Life Sciences with 5-8 years of experience in the pharmaceutical industry, preferably in Regulatory Affairs and /or Clinical Research
·Ability to work on extremely complex problems and/or data
·Exercise independent judgment in developing regulatory strategies and solutions to regulatory problems
·Extensive knowledge of FDA regulatory requirements and knowledge of appropriate regulatory requirements outside the U.S.
·Excellent organizational skills and attention to detail
·Strong communication and interpersonal skills
·Excellent writing skill and ability
·Ability to work in a computerized environment, with basic knowledge of MS Office, databases, etc.
·Ability to act independently to determine appropriate methods and procedures on new assignments
·Prior management experience preferred

MINIMUM EDUCATION LEVEL: University - Bachelor Degree