Associate Director, US Regulatory, Advertising & Promotion. Associate Director, Commercial Regulatory Affairs. The Associate Director, Commercial Regulatory Affairs will report to the Sr. This position requires frequent interaction and strong collaboration with Commercial Marketing, Medical Affa...
As the Senior Manager/Associate Director ofRegulatory Strategy, you will play a critical role in driving the developmentand execution of regulatory strategies for our rare disease therapeuticprograms. Develop and implement globalregulatory strategies for rare disease therapeutic programs, ensuring a...
Reporting to the Director, Regulatory CMC, the Associate Director of Regulatory CMC will be responsible for the development and submission of regulatory filings for CRISPR/Cas9- based gene therapy projects, in the US and internationally. Identify and clearly communicate regulatory opportunities and ...
The Associate Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory labeling, especially the generation of new US prescribing information and changes to existing labeling, and submission of labeling information to Health Agencies. Serve as...
Kirby Bates Associates, a national healthcare leadership firm, has an engagement opportunity for an Interim Manager/ Documentation Regulatory Specialist in Massachusetts at a residential and LTC facility. The leader must be able assist at the unit levels with hands-on monitoring and mentoring and ha...
The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collabo...
Feldesman Leifer LLP, a boutique law firm with offices in Washington, DC and Sacramento, CA, seeks a highly capable associate with three or more years of relevant experience and general knowledge of the health care delivery system. The ideal candidate will have a solid understanding of the regulator...
Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for people with solid tumors/lung cancer and rare endocrine diseases, who are searching for a Director / Senior Director of Regulatory Affairs. Serve as the Regulatory Affairs representativ...
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...
The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements a...
Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission. Prepares, edits, and finalizes synopses, ...
Our client is in search of candidates who demonstrate a keen interest and enthusiasm for tackling the intricate regulatory and policy challenges within the Medicaid program. This includes assisting with transaction structuring and negotiation, providing strategic counsel on regulatory and compliance...
The Associate Director of Regulatory Affairs will be responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects. The Associate Director Regulatory Affairs will be responsible for oversight of the operational execution of Regulatory submissions fo...
Job DescriptionPosition Summary: 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 r...
The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. The Device Regulatory Lead for Specialty Care & Vaccine Combination Products will oversee key regulatory activities and report to the GRA Device Team Leader for Specialty Care & Vaccine Combina...
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. Associate Director, ...
Track regulatory project status and informational documents. Interfacing with global regulatory partners and internal cross functional teams. Minimum of 3-6 years Regulatory Affairs experience required; biologics experience required. Clear understanding of content and organization of regulatory subm...
The Associate Director, Clinical Regulatory Medical Writing manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of ...
As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strategies where little precedent exists. Act as Regulatory CMC Lead for assigned programs providing strategic guidance to development teams on complex Regulatory CMC topics. Pa...
Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs**+ Location: Bridgewater, NJ or Cambridge, MA**About the job**The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for products in the Rare Disease, Rare Bl...
The Associate Director of Regulatory Affairs Strategy will be responsible for developing regulatory strategies to support clinical development plans, working cross-functionally across the organization. Associate Director, Regulatory Strategy. Associate Director of Regulatory Strategy. Ensure adheren...
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...
As a Regulatory Affairs Consultnat you will lead regulatory projects and provide regulatory guidance IVD device manufacturers. Responsibilities Providing regulatory guidance and developing strategy to support Client/Sponsor regulatory and market objectives Developing FDA Q-subs in collaboration...
Supports financial, regulatory and policy research in support of regulatory activities. Assigned to support several different regulatory initiatives and proceedings and will be expected to work closely with a variety of staff, teams and managers. Will work under primary direction of the Manager, Reg...
The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. This goal must be achieved both as a component of an overall glo...