Clinical Regulatory Affairs Associate Job in North Chicago 60064, Illinois US
Clinical Regulatory Affairs Associate
Abbott Park, IL
Primary Job Function: Independently: 1. Product registrations /Submissions -Identifies/obtains data needed, and ensures that they are effectively presented for the registration of products -Assesses scientific data provided by specialist units for registration purposes against regulatory requirements -Manages the preparation of registration packages (including complex) and answers to deficiency letters -Ensures records of filings and approvals are maintained -Approves the complete regulatory data packages prior to filing and during the approval process -Prepares agency meeting packages, and develops strategies for agency meetings 2. Relationships Cross Functional team work - Represents Regulatory Affairs at relevant meetings e.g. Brand team, Product Workstream, CMC Workstream and presents agreed RA position and negotiates with and influences management (Manufacturing, Quality, Development, Commercial etc.) to ensure programs meet regulatory requirements - Monitor actual vs. planned activities and timelines. - Identify issues impacting project progression. -Participates in agency meetings as appropriate -Trains, develops and mentors individuals; may include formal supervisory responsibilities 5. Strategy . Advises Business Partners ( e.g. Commercial, Development, QA, Manufacturing, New Business Development) on global regulatory requirements -Defines regulatory strategies for the registration of products -Facilitates policy development and standard interpretation of regulations -Provide regulatory expertise to licensing departments 6. Process Improvement -Identify and implement process improvements -Implement position papers work aids etc -Identify opportunities for business and efficiency improvements Minimum Education: Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject A relevant Masters Degree is preferred 7 years in RD or related area; ideally includes 5 years in Regulatory
Please respond with a copy of your resume sent to rahul.k@ustechsolutions.com / garima@ustechsolutions.com