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...
IVD or medical device FDA registration.International Device Licensing and Registrations.FDA and other inspection agencies as needed....
IVD or medical device FDA registration.International Device Licensing and Registrations.FDA and other inspection agencies as needed....
The Senior Regulatory Affairs Manager is a key member of the Legal, Regulatory Affairs & Compliance (LRAC) team. The Senior Regulatory Affairs Manager will also serve as the LRAC subject matter expert for all project implementation work associated with the assigned portfolio of regulations. The ...
Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Develops detailed regulatory project plans and lead or support regulatory activities relating to specific portfolio of prod...
BioTalent is representing a top-tier life sciences device manufacturer hiring a Regulatory Affairs Manager ensure compliance with global regulatory requirements while managing the regulatory affairs team. Oversee the preparation of regulatory submissions, ensuring accuracy and compliance with all re...
Lead regulatory affairs activities, including the preparation of regulatory submissions and interactions with regulatory authorities. We are seeking Quality Assurance & Regulatory Affairs Manager to join our dynamic team. This is an exciting opportunity for a seasoned Quality Assurance & Regulatory ...
The Senior Regulatory Affairs Manager is a key member of the Legal, Regulatory Affairs & Compliance (LRAC) team. Regulatory Affairs Manager-(3291838). The Senior Regulatory Affairs Manager will also serve as the LRAC subject matter expert for all project implementation work associated with the assig...
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...
Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects. Responsible to communicate new regulatory guidelines. Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update ...
Job title: Senior Manager, US Advertising & Promotion, Global Regulatory Affairs**+ Location: Bridgewater, NJ or Cambridge, MA**About the job**Under the direction of the Director, this individual will be responsible for providing US regulatory review and approval of promotional and other product 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...
Lead regulatory affairs activities, including the preparation of regulatory submissions and interactions with regulatory authorities. We are seeking a highly motivated and experienced Quality Assurance & Regulatory Affairs Manager to join our dynamic team. This is an exciting opportunity for a seaso...
The Senior Grants and Contracts Manager will support innovative research at the world's leading public health research institution, primarily in the Department of Global Health & Population. The Senior Grants and Contracts Manager is an integral part of the research enterprise and works in close par...
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 successful manager will be an active member of the Regulatory Affairs leadership team and manages department activities with responsibility for results in terms of costs, timing, methods and employees. Responsible to implement policies, procedures, practices and strategies for Regulatory Affairs...
Reporting to the Global Head Regulatory Affairs this position will collaborate closely with the broader regulatory & scientific affairs team. Regulatory & Scientific Affairs Manager - This position may be based in Decatur, IL; Quincy, IL; Harvard, IL; or Fort Collins, CO. Lead a team of 5 Regulatory...
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...
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...
Program Manager, Regulatory Affairs. You will develop regulatory strategies and regulatory submissions for new and modified products to the FDA and International regulatory bodies. In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and bi...
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...
Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development p...
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...
Job title: Senior Manager, US Advertising & Promotion, Global Regulatory AffairsLocation: Bridgewater, NJ or Cambridge, MAAbout the jobUnder the direction of the Director, this individual will be responsible for providing US regulatory review and approval of promotional and other product and disease...