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About our client
Our client is a dynamic and growing, independent contract drug development and consulting company. Employees at this company are experienced and highly qualified team players, essential to its success.
Position	Location
Director of Regulatory Affairs	West Coast
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Direct/handle regulatory project management 2) Provide regulatory counsel for internal and external drug development programs 3) Manage projects to budgets and timelines 4) Provide leadership in non-clinical, clinical or CMC areas 5) Prepare and submit INDs, ANDAs, NDAs, 510Ks, PMAs, BLAs and submissions/approvals 6) Facilitate understanding of electronic submissions including, core dossier 7) Work with the VP of Regulatory Affairs in development and implementation of strategy, to maintain an efficient and compliant Promotional Review Board (PRB) process 8) Liaise with the FDA (external) and with Marketing/Regulatory/Medical/Sales and Legal (internal) in support of initiatives as well as PRB process and review of promotional materials 9) Develop and maintain positive rapport and working relationships within and across departments 10) Provide high-level consulting services 11) Hire, train and lead Regulatory staff
Requirements
1) Bachelor’s degree in a relevant field (Pharm.D. or Ph.D. preferred) 2) 7 – 10 years of experience in the pharmaceutical, drug and/or device industry (with emphasis on regulatory drug development) 3) 5+ years in a managerial role with at least 2 reports 4) In-depth knowledge of and experience in a RA Department 5) Knowledge of FDA divisions, personnel, and procedural concepts 6) Experience in NDAs, including preparing documents for eCTD submissions 7) Expertise in the Division of Dermatology and Dental Drugs of the FDA preferred 8) Knowledge of all FDA regulations to support filings (as they apply to preclinical and clinical disciplines) 9) Ability to be a leader, collaborator and coach 10) Ability to work in close collaboration with others across the organization 11) Ability to work independently and use good judgment in problem-solving and decision-making 12) Proficient in computer and database management 13) Ability to write and establish policies and procedures 14) Excellent communication skills (verbal and written) 15) Superb organizational and planning skills 16) Ability to multi-task and complete tasks/objectives in a timely manner 17) Keen attention to detail, with the ability to ensure work is completed with accuracy and in accordance with established procedures