We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory...
The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory functions across POC's Portland & Gardner site...
The Regulatory Affairs team at Entrada is a dynamic, growing team that develops and executes innovative regulatory strategies to efficiently advance Entrada’s pipeline of intracellular therapeutics for the treatment of devastating diseases. Reporting to the Senior Vice President, Regulatory Affairs,...
Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions, and feedback to the teams in support of regulatory approvals. Mantell Associates is currently partnered with an innovative Biotech company, developing much-...
Oversee the preparation, review, and submission of regulatory filings, including INDs, BLAs, NDAs, MAAs, and other regulatory documents, ensuring compliance with regulatory requirements and timelines. Cultivate strong relationships with regulatory authorities, including the FDA, EMA, and other globa...
As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscap...
Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Ensures that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current r...
ICP Group is looking to identify a Product Safety & Regulatory Affairs Specialist. The PSRA Specialist ensures that all product-related activities (from development to post-commercialization) are conducted in accordance with the current domestic and global regulatory statutes that govern the respect...
The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Completes and submits all required Federal and State reports and acts as a liaison ...
Senior Regulatory Affairs Specialist. Responsible for managing product based regulatory activities of a medical device company that designs, manufactures, sells, and services medical imaging equipment. Manage preparation of regulatory documentation to facilitate the commercialization of new products...
The Senior Regulatory Affairs Manager is a key member of the Legal, Regulatory Affairs & Compliance (LRAC) team. Regulatory Affairs Manager-(3291838). This position will report to the Director, Legal, Regulatory Affairs & Compliance, and will take the lead on managing a portfolio of federal regulati...
Must have previous experience in conducting all regulatory affairs activities including meeting submissions, IND, and clinical trial applications and regulatory filings. Requires experience in the management of regulatory documentation and compliance, and in the management of a regulatory functional...
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Associate Director/Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information related to assigned Alkermes produ...
Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (, commercial, research, clinical development, medical affairs, business development, legal, manufacturing, qual...
Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/adverti...
The Director, RA CMC Combination Products will work cross-functionally to lead development and implementation of global combination product/Medical Devices regulatory strategies across all applicable programs and lifecycle stages in accordance with program objectives. This position serves as the Reg...
Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships. Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on reg...
The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects. Management of facilities and equipment matters required for INDs, registration a...
The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Maintain Regulatory affairs documentation to support compliance with applicable regulato...
Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics. Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs supports a portfolio of small molecule development programs and m...
Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strateg...
Prior experience must include: Vendor and Client Management for Regulatory Operations – Manage relationships with vendors and clients for various regulatory operations services; Identify and evaluate potential eCTD submission vendors based on their experience, expertise, cost-effectiveness, and trac...
Manages the organizational structure, staffing, resourcing, and supervision of the Global Regulatory Affairs function including line management responsibilities for multiple Regulatory Affairs sites and/or regions. Experience with supervisory and financial management responsibility of a regulatory a...
Director Regulatory Affairs Professional, Ad & Promo. Neurology Regulatory Affairs team of a global biopharmaceutical company as . Director of Regulatory Affairs (Ad & Promo). Responsibilities for the Associate Director of Regulatory Affairs Advertising & Promotion include:. ...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...