Location: Somerst County, New Jersey and Bergen County, New Jersey
Salary: $105,000 to $125,000 + Bonus Total Compensation could go as high as $150+
Description:
The Director/Manager, with minimal guidance, is responsible for the supervision/preparation and critical review of high quality regulatory submissions to the FDA including ANDAs, amendments, supplements, and annual reports. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to the Associate Director or Director. The manager, with minimal guidance, evaluates changes and signs-off on change control documents, ensuring the correct filing category. He/she represents Regulatory Affairs on project teams and serves as team leader for projects. Responsibilities: ? Manages the regulatory associates in the preparation, compilation and submission of high quality ANDAs, amendments, supplements, annual reports, control documents, etc. to FDA authorities. ? Critically reviews regulatory submissions and assigns signature for approval. ? Manages quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution. ? Interacts between departments to coordinate and facilitate submissions. ? Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. ? Works to minimize regulatory issues and helps prevent unnecessary regulatory delays. ? Stays abreast of Regulatory initiatives and changes within FDA and stays current with additions or changes on the FDA website. ? Coaches, mentors and provides guidance to the regulatory associates. ? Evaluates changes to regulatory documents and formulates a strategy to ensure proper filing categories. ? Represents Regulatory Affairs on project teams. ? Interacts with FDA and all of the company's sites via written and phone communications. ? Other duties, as assigned, or as business needs require. Qualifications: Must Have Recent Generic Pharmaceutical Experience! ? Technical: Possesses a strong technical knowledge and demonstrates thorough understanding of all FDA requirements pertaining to submission of regulatory documents. ?Problem Solving: Demonstrates excellent organization skills and the ability to multi-task; detail oriented with an ability to produce work to a very high standard. Demonstrates an ability to negotiate responses to FDA deficiencies in a manner acceptable to both FDA and Company's departments. Demonstrates judgment in determining whether an ANDA is sufficiently complete to be accepted for filing by OGD, or whether it will be refused. Demonstrates advanced judgment in determining whether an amendment or supplement is sufficiently complete to be reviewed by FDA with minimal, if any, comments. ?Interpersonal: Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts. ?Communication: Demonstrates excellent verbal and written communication skills. Shares concepts, ideas, information, and suggestions with management, peers and others. ?Problem Solving: Demonstrates the ability to evaluate regulatory documents and determine appropriate action. Demonstrates the ability to provide regulatory assessment to other departments with little or no supervision. Demonstrates the ability to coordinate submissions independently in a time intensive situation.
Contact: Robert Fisher Complete Personnel Services, Inc. Technical Placement 10 North Gaston Avenue Somerville, New Jersey 08876 (908) 704-1770