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...
Takeda Development Center Americas, Inc.Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics....
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials. Employs a current...
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...
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-...
They are a primary resource for providing guidance and oversight on issues related to fiscal, administrative and regulatory management of a portfolio of grants, contracts and sponsored programs from award receipt through closeout. ...
Global Head of Regulatory Affairs is. Reporting to the CEO the SVP/VP Global Regulatory Affairs drives the articulation and. In the short-to-mid term the SVP/VP Global Regulatory Affairs primary focus shall be the. Hire, train, and manage regulatory affairs department (currently six staff). ...
A minimum of 10 years' experience in Pharmaceutical Regulatory Affairs/Regulatory Intelligence across major markets (Europe, North America, Asia Pacific) in Life Science industry and/or in consulting companies. We help companies advance their drug discovery, preclinical proof-of-concept, and regulat...
The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting regulatory strategy and registration across global markets across the entire Regulatory Affairs group. Individuals will be expected to help drive regul...
As a Regulatory Affairs Consultnat you will lead regulatory projects and provide regulatory guidance IVD device manufacturers. Providing regulatory guidance and developing strategy to support Client/Sponsor regulatory and market objectives. IVD Regulatory Affairs experience with Clinical Trial Manag...
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:. ...
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...
As the Director of Regulatory Affairs in the medical device industry, you will play a pivotal role in ensuring that our products comply with all applicable regulatory requirements and standards. Leveraging your extensive knowledge of regulatory processes, you will lead the development and implementa...
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...
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...
Manager, Global Regulatory 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 submissions are provided to local Takeda affiliates in compliance w...
IVD or medical device FDA registration.International Device Licensing and Registrations.FDA and other inspection agencies as needed....
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...
The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department. Key Responsibilities: Regulatory Affa...
Responsible to communicate new regulatory guidelines. Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects. Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update ...
Regulatory Affairs Specialist (Level II or Senior Level). BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred. ...
The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfoli...
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...
Regulatory Affairs representative for the CT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of ...