|
About Dow Pharmaceutical Sciences, Inc.:
 compress
Dow Pharmaceutical Sciences, Inc. is a privately held, dynamic and growing independent contract drug development and consulting company, specializing in dermatological, opthalmic, and other topical products. We provide individual or integrated services to clients including formulation development, analytical and stability, clinical trial materials and regulatory and clinical affairs. Pharmaceutical development employees at Dow Pharmaceutical Sciences, Inc. are experienced, highly qualified team players, essential to the success of our company.
Click here to go to the Dow Pharmaceutical Sciences, Inc. website.
For details about Dow Pharmaceutical Sciences, Inc., click here.
About the Opportunity/Requirements:
compress
The Director, Regulatory Affairs will be responsible for technical leadership, project management and consulting activities. Responsibilities include the following:
• Direct / manage regulatory project management.
• Provide regulatory counsel for internal and external drug development programs.
• Manage projects to budgets and timelines and provide leadership in non-clinical, clinical, or CMC areas.
• Prepare and submit INDs, ANDAs, NDAs, 510Ks, PMAs, BLAs submissions/approvals.
• Facilitate understanding of electronic submissions including CoreDossier.
• Work with the VP, Regulatory Affairs in development and implementation of strategy to maintain an efficient and compliant PRB process.
• Liaison with the FDA (external) and with Marketing/Regulatory/Medical/Sales and Legal (internal) in support of initiatives and Promotional Review Board (PRB) process and review of promotional materials.
• Develop and maintain positive rapport and working relationships within and across departments in this effort.
• Provide high level consulting services.
• Hire, train and lead Regulatory staff.
Job Requirements:
• Demonstrated abilities as a leader, collaborator and coach.
• Ability to work in close collaboration with others across the organization.
• Ability to work independently and use good judgment in problem solving and decision making.
• Quality minded with ability to ensure that work is completed with accuracy and in accordance with established procedures.
• Ability to write and establish policies and procedures.
• Verbal and written communications must be effective and well focused.
• Strong organizational and planning skills with ability to multi-task and complete tasks/objectives in a timely manner.
• Computer and data base management literate.
Education/Experience/Training:
• Minimum Bachelors degree in relevant field; Pharm.D. or Ph.D. preferred.
• Seven to ten years experience in the pharmaceutical drug and/or device industry, with emphasis on regulatory drug development.
• Five or more years in management role with at least 2 or more reports.
• Must have knowledge of all FDA regulations to support filings especially as they apply to preclinical and clinical disciplines.
• Thorough working experience in a regulatory affairs department with knowledge of FDA divisions, personnel, and procedural concepts.
• Direct experience with NDAs, including preparing documents for eCTD submissions.
• Experience with the Division of Dermatology and Dental Drugs of the FDA is preferred.
|
Print
This Page
