Regulatory Specialist

Description:

Responsible for the review and evaluation of all FDA submissions to assure accuracy and completeness of submission documents for IND/NDA/ANDA products.

Responsibilities:

• Determines submission requirements and requests needed data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate.
• Reviews and provides comment for reports and amendments to INDs/NDAs, assuring submission within specified regulatory timeframes. Reviews and provides comment for accuracy and completeness all materials to be included in submissions, including materials prepared by others and supplied to Regulatory.
• Responsible for preparing Regulatory Module 1 documents, including labeling markups and annotations for submission.
• Interacts with all department, facilities, and affiliates with regard to investigational and marketed products for required information and documentation.
• Contributor for regulatory guidance regarding investigational and marketed products (U.S. and Canada).
• Advises Regulatory Management of any delays in submissions or potential regulatory problems for investigational and marketed products (U.S. and Canada).
• Performs other projects, project-based tasks and/or special projects as assigned by Regulatory Management.

Additional Skills & Qualifications:

• 4-7 years regulatory affairs experience, with a minimum 3 year of FDA submissions experience (IND/NDA/ANDA) required.
• Requires excellent verbal and written communication skills for interaction with all levels of personnel in the corporation.
• Must have good analytical reasoning, must be detail and solutions oriented and must be able to work in a team environment. Must have ability to develop, articulate, and adequately explain decisions, opinions, and recommendations in implementing and interpreting, implementing and applying complex regulatory rules, regulations, guidance's, and instructions to company products and projects.
• Requires moderate to high level competencies in operation and manipulation of PC-based office equipment and related database and word processing software.
• Must maintain competence in current regulatory issues and requirements by vigilance in reviewing available printed and electronic literature, and by attending professional seminars, workshops, classes, and meetings as appropriate.