Details: At 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. Job Title: Regulatory Affairs Manager/Sr. ManagerJob Location: Bridgewater, NJProvide strategic regulatory support to all functional groups in alliance projects with contract manufacturers.Create, organize and manage the preparation of all types of FDA submissions.Coordinate activities required for timely and accurate reporting of information.Advise the Company on relevant new and existing regulatory strategies, risks and compliance requirements and provide regulatory expertise, advice and support for ANDA, NDA 505(b)(2) submissions.Advise the team on bioequivalence/clinical strategies for more complex generic formulations.Foster collaborative, efficient and effective working relationships with contract manufacturers, internal Dr. Reddy's team and FDA in order to further build collaborative working relationships.Respond to queries from FDA associated with ANDA/NDA 505(b)(2) submissions.Assist U.S. Agent in reviewing all pre-approval and post-approval submissions from internal team in accordance with current regulations from US FDA (mandatory) and Health Canada (preferred). This review includes a detailed scientific/regulatory review ensuring compliance to all appropriate regulations. Communicate significant and/or potential issues to U.S. Agent.Provide strategic regulatory advice on -re-ANDA activities; specifically, providing clarity to inactive ingredient database controlled correspondences, bioequivalence recommendations, and meeting requests for NDA 505(b)(2)s.Independently review and provide feedback to the promotional review committee related to promotional marketing items.Ensure appropriate communication is provided to upper management on any regulatory/compliance issues.Assess and justify the appropriate category for post-approval change classifications.Provide guidance, advice and training to junior staff members. This function may or may not include supervision of direct reports.
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