- ITG Brands (Greensboro, NC)
- …staff members, to ensure US and Global product initiatives meet both regulatory and compliance guidelines by partnering with local and global ... Lead team functioning as point of contact for US regulatory product compliance for all...for all US marketed products and specification management of Global MMC markets. - WHAT YOU WILL DO _(This… more
- Formation Bio (New York, NY)
- …to developing and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle ... globally, coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative… more
- Eisai, Inc (Nutley, NJ)
- …is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage ... regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the integrity, transparency, and governance of global forecasts, ensuring compliance with internal policies and external regulatory requirements.Lead audit ... with Market Research, Competitive Intelligence, Marketing, Medical Affairs, R&D, Finance, Regulatory , and Market Access internally across global and regional… more
- Insmed Incorporated (NJ)
- …for both clinical and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our clinical and ... small molecule process chemistry, formulation, and analytical development.Demonstrated success in regulatory submissions and global CMC regulatory … more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, ... label language against regulatory requirements. + Maintains awareness of global regulatory legislation and assesses impact to active marketed, established… more
- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play… more
- Olympus Corporation of the Americas (Westborough, MA)
- …delivery. + Strong ability to align digital, business, and R&D leadership on global regulatory expectations, balancing compliance with innovation. + Strong ... world-class regulatory strategies for digital health solutions, ensuring compliance with applicable global requirements while proactively navigating evolving… more
- Parexel (Columbia, SC)
- …for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional ... on impactful global programs that directly support patient safety and regulatory compliance . - Collaborate with a diverse, international team across multiple… more
- Teleflex (Wyomissing, PA)
- …Update and maintain EU MDR technical files and documentation to ensure continued compliance . - Support regulatory compliance activities, including Health ... requirements. The Senior RA Associate will partner with Product Management Regulatory Affairs personnel to support...working with cross-functional teams. Preferred: - Basic medical device global regulatory knowledge base (outside of the… more
