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 Senior Manager/Director of Policy and Regulatory Affairs will play a pivotal role in shaping and advancing our client's strategic initiatives across PJM and regulatory landscapes. Director of Policy & Regulatory Affairs | Eastern US, REMOTE |$165k - $175k base + bonus. Are you a regulatory affai...
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...
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...
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...
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Collaborates with other functional work teams , Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of glob...
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...
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...
Regulatory Affairs Manager III. This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submissi...
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...
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...
Actively participate in problem solving discussions and recommend solutions • Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies • Assist in the maintenance and improvement of regulatory SOPs • Interact and negoti...
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...
Provides leadership for all activities relating to the development and management of the Plan’s quality improvement and accreditation activities including NCQA, contractual and regulatory quality requirements and measures for all lines of business, HEDIS/Performance Improvement, clinical quality pro...
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...
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...
This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. The Associate Director will b...
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...
Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements. Communicate/liaise with clients, regulatory agencies/competent authorities...
Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory agencies, CROs, consulting groups, and other third parties. Significant regulatory affairs experience is required. Provides stra...
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...
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. ...
Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Senior Regulatory Affairs Specialist. Serve as RA Repre...