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...
CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Global Health Authoritie. ...
Conceive of and Implement the Regulatory Strategy in collaboration with Cross-Functional (Solution Leaders, SBU Marketing, Medical Affairs, BU Regulatory and other) partners. The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compl...
Affairs, Marketed Products in Cambridge, MA to Assist the Global Regulatory Lead (GRL) and is accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissio. ...
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...
The SVP, Global Regulatory Affairs is responsible for leading, managing, and driving all aspects of the Regulatory Affairs function, including leading the Global Regulatory Strategy team. This role partners with the Chief Regulatory Affairs Officer (CRAO) and Global Regulatory Program Leads to devel...
Prior experience must include: Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and effi...
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development. Demonstrated ability to deal with issues of critical importance, provide regulatory advice and experi...
Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor’s degree in a scientific field or foreign academic equivalent plus 4 years of related experience. Required skills: Ability to work with firm deadlines and adapt quickly to changin...
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...
At this level, the incumbent independently manages a major segment of the Company’s regulatory effort and serves as the prime regulatory consultant and external spokesperson on key matters with regulatory agencies and the Company’s top management; works under consultative direction toward long-range...
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...
Director, Global Regulatory Affairs, Development Strategy. Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i. Providing support to regulatory affairs reviewers...
The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi’s diversified portfolio in order to meet corporate and business objectives. At least 8-10 yea...
The (Senior) Director, Business Planning & Operations, is responsible for managing business processes in the Alexion Regulatory Affairs team and is a member of the Alexion Regulatory Affairs Leadership Team (RALT). Senior Director, Business Planning & Operations, Regulatory Affairs. Works closely wi...
Regulatory experience of submitting clinical trial applications (CTA, IND & EUCTR) within a pharma/biotech. If you have lead the regulatory submissions of clinical trials in Canada, Europe & the U. ...
The successful candidate will support regulatory activities at Yield10 Bioscience including drafting, securing, and submission of USDA-APHIS BRS permits and notifications for movement and release of regulated crop material, overseeing regulatory matters of field trials, and supporting other regulato...
Director, Regulatory Affairs U. Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam’s marketed products, investigational treatments, and disease areas to healthcare providers, patients, payers, and...
The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory aff...
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...
Prior experience must include: Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and effi...
Regulatory Affairs Specialist (Level II or Senior Level). BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred. ...
Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs. As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and appli...
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...