Associate Manager/ Manager Regulatory Affairs - Dr. Reddy's (Bristol, TN)
Posted: Wednesday, January 23, 2013 7:18 PM
Job Number : 3329973Job Title : Associate Manager/ Manager Regulatory AffairsBusiness Unit : Dr. Reddy''s TennesseeLocation : Bristol, TNAt Dr. Reddy’s, a global pharmaceutical company, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.Please Note: Unless an order has been placed with your agency for this role, we will not accept any calls or other inquiries from recruiters for this position. If a candidate is submitted despite this, we are not bound by any agreement terms and can hire the person as we see fit.Independently manage preparation, submission and monitoring progress of FDA review of NDA’s and ANDA’s. Experience working on NDA’s is preferrable. Includes communication with FDA by telephone, direct contact or letter. Communication with DR. REDDY’S functional groups (Research, Regulatory Affairs, QC/QA, Product Development, Marketing, etc.) for coordination and preparation of data for submission to FDA or other regulatory agencies. Coordinate plans of action and status reports with Manager and support development of important policy decisions. Routine policy decisions made independently or with consultation of Manager. Entails independent planning and execution. Make recommendations regarding compliance of documentation, reporting status of adverse reaction and various other regulatory requirements (format of reports, conduct of investigations, etc.). Recommendation of action made to others usually resulting from FDA requests for additional information, FDA citations or internal problems requiring preparation of data or responses by other departments. Internal: Regulatory interface with Regulatory Affairs, Research, Product Managers; QC and Product Development in regards to format of reports for submissions to FDA, adverse reaction reports, compliance with Good Manufacturing Practices Regulations; manage the preparation and status of pending supplemental applications, and assist in appropriate management review and approval. Create and maintain a document management system with appropriate distribution for regulatory documents. Manage all reporting and interaction requirements for regulated products. Manage review of internal document system for compliance to Regulatory commitments. Manage all Regulatory, Federal and State License requirements for Dr.Reddy’s sites. External: Regulatory interface with regulatory agencies, FDA, and DEA personnel in regards to submissions and questions.Strong knowledge of pharmaceuticals industry, including generic products; Strong knowledge of approval process for new NDA and ANDA products. Strong knowledge of USFDA regulations. Experience working on routine submissions. Ability to understand and communicate legal risk. Proven ability to anticipate challenges and negotiate through them to achieve desired outcome. Ensure appropriate maintenance of regulatory document files. Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously. Ability to follow written and verbal directions with a high level of accuracy. Position requires attention to detail and ability to work as a team player. Willing to work with a diverse cultural group.From unsurpassed career momentum to our innovative perks and benefits, we do everything we can to make sure our employees not only do exceptional work, but have exceptional rewards, as well. If you are committed to making a profound impact worldwide, we invite you to learn more about our career opportunities, our products, and our plans for the future. Please visit us at w.drreddysusjobs.com.**We are a corporate office and not a doctor’s office. Unsolicited resumes sent to our office will not be considered for any open positions. Only interested parties that apply through our Career website will be considered for positions within Dr. Reddy''s Laboratories, Inc.**As an Equal Employment Opportunity/Affirmative Action employer, Dr. Reddy’s Laboratories, Inc. and its subsidiaries, does not discriminate in employment against applicants or employees on the basis of race, color, religion, sex (except where sex is a bonafide occupational qualification), national origin, age, mental or physical disability, status as a disabled veteran, armed forces service medal veteran, other protected veteran, or recently separated veteran, or any other basis prohibited by federal, state or local law.
• Location: Tri-Cities, Bristol
• Post ID: 6922285 tricities