Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage cli

Site Name Belgium Wavre, Italy Siena, UK London Brentford, USA Massachusetts Waltham Posted Date May 27 2024 Job purpose As the Director Vaccines Development CMC you, Are responsible for CMC (Chemistry, Manufacturing and Controls) Regulatory strategy and deliverables for a specific asset of vaccine development products, including in licensed assets, through to commercial

Develops, maintains and manages all plan fee schedules and code pricing. Monitors multi state regulations including DHHS, EOHHS, and CMS websites, listservs and other sources to identify existing payment practice and proposed changes. Determine the scope and impact of the change on Plan operations and seek to implement changes as necessary. Business owner in managing soft

Site Name USA Maryland Rockville, Cambridge Binney Street, Durham Blackwell Street, USA Pennsylvania Upper Providence Posted Date May 22 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent an

The Principal Regulatory Specialist is responsible for carrying out Pre Market and Post Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. This role shall provide product level leadership and initiative by independently developing and executing regulatory strategies

Lead the management of a portfolio of federal regulations, inclusive of policy development, external advocacy work, and gathering internal feedback in support of the advocacy work. Serve as the regulatory subject matter expert on implementation projects impacted by federal guidance and/or regulations. Advise business stakeholders within Mass General Brigham Health Plan on

Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas SBSE Small Business/Self Employed, SB/SE Deputy Commissioner Exam, Specialty Examination, Estate & Gift /Excise Tax Exam The following are the duties of this position at the full working level. If this vaca

Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than

Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features. Essential Functions Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval. Ensure project team colleagues, line management, and k

If you are passionate about innovative therapies, love leading complex regulatory filings, and live for quality, on time, and within budget project deliverables, Parexel is E X P A N D I N G and we currently have openings for Senior Regulatory Affairs Consultants / Regulatory Affairs Leads. These are incredible opportunities to join a tight knit team of amazingly nice and

of Role Responsible for integrating and applying advanced knowledge of global regulations governing pharmaceutical drug development and commercialization to all aspects of assigned preclinical and/or clinical drug development programs, policies, and procedures, to ensure the rapid and successful development and registration of products while maintaining compliance with all

of Key Responsibilities Provides leadership and guidance to various stakeholders to ensure development and implementation of innovative global regulatory strategies across Alnylam's portfolio of combination/device products Provides technical, strategic and tactical regulatory guidance to matrixed product development teams Defines and optimizes global regulatory strategies

Parexel's Strategic CGMP Compliance team is known for our unparalleled breadth and depth of expertise globally. Parexel CGMP Compliance offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre eminent regulatory and GxP (Good Clinical

Recruiter Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan's goal is to simplify, standardize and modernize our core business processes, enabling BSC to better leverage the power of data and to position our business for pr

Site Name USA Pennsylvania Upper Providence, GSK House, Switzerland Zug, USA Massachusetts Waltham, USA North Carolina Durham Posted Date May 16 2024 Purpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic