Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred. Regulatory Affairs, Adve...
The Senior Manager, Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global team of public policy and regulatory affairs experts. Play an active role in supporting the execution of key projects within the International Government & Regulatory A...
Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. What do we expect from you as a Consultant Regulatory Affairs IVD?. EU and preferably also in non-EU Quality Systems & Regulatory Affairs consulting for In Vitro Diagnostics (I...
As a Senior Regulatory Affairs and/or Quality Affairs Consultant you work closely with our Head of Regulatory to support medical device (MD), in-vitro diagnostic medical devices (IVD) with a focus on software as medical device (SaMD), including AI as a medical device (AIaMD), companies to bring thei...
Are you looking for an opportunity where you can use your expertise to provide strategic, technical, and regulatory guidance for clinical development and drug development life cycles? A role where you can lead regulatory consulting services and maintain technical knowledge in product development and...
Support the lead regulatory strategy for late-phase oncology programs, ensuring alignment with global regulatory requirements. Minimum of 8 years of industry experience, with at least 4 years in regulatory affairs. Strong technical proficiency in regulatory affairs is crucial. The client is seeking ...
Collaborate with cross-functional teams to develop and implement regulatory strategies, manage regulatory risks, and ensure compliance with current regulations for cell therapy products. Prepare and manage regulatory submissions (INDs, CTAs, BLAs/MAAs) to agencies like the FDA and EMA. Ensure qualit...
Demonstrated ability to drive high-level regulatory strategy and navigate complex regulatory landscapes. The client is seeking a highly experienced professional to lead their regulatory strategy for a late-phase oncology program. Spearhead regulatory submissions for the oncology portfolio, driving s...
The Regulatory Affairs Manager will collaborate closely with the Regulatory Affairs Team Lead and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines. The Global Regulatory Affairs Manager direct...
Minimum of 10 years in the industry, with at least 8 years dedicated to regulatory affairs. Demonstrated ability to drive high-level regulatory strategy and navigate complex regulatory landscapes. The client is seeking a seasoned professional to lead their regulatory strategy for a late-phase oncolo...
Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred. Regulatory Affairs, Advertis...
Partners with and helps key stakeholders' teams to implement reporting and quality improvement projects in help of BSWH's strategy to deliver high-quality, safe care and achieve excellence in accordance with regulatory statues, policies and procedures. Helps and/or facilitates departmental processes...
This position will receive continuous guidance and mentoring by the Director of Regulatory Affairs and/or the Deputy Chief Regulatory Officer and the Chief Regulatory Officer, as applicable. The Manager of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regula...
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Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
Reporting to the Vice President of Global Regulatory Affairs (GRA), the Director of Chemical and Biological Regulatory Affairs will be responsible for setting the strategy for and leading the Chemical/Biological Regulatory Affairs team within the Global Regulatory Affairs organization. Assists in th...
Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients.USP's fundamental belief that Equity = Excellence manifests in our c...
Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulat...
Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred. Regulatory Affairs, Advertis...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
The Senior Regulatory Affairs Director (RAD), Global Regulatory Strategy. To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of. Regulatory Affairs Strategists. You will work across disciplines in an atmosphere of collaborati...
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...
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company ...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
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...