- Merck & Co. (Rahway, NJ)
- …purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which ... and guidance to teams while ensuring compliance with applicable regulatory requirements- Serving as regulatory labeling...Representatives Please Read Carefully-Merck & Co., Inc., Rahway, NJ, USA , also known as Merck Sharp & Dohme LLC,… more
- Merck & Co. (North Wales, PA)
- …communicates regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling , Regulatory Chemistry, Manufacturing and ... all aspects of planning and implementation of a global regulatory strategy and regulatory submissions...Representatives Please Read Carefully-Merck & Co., Inc., Rahway, NJ, USA , also known as Merck Sharp & Dohme LLC,… more
- Merck & Co. (Rahway, NJ)
- …growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their assigned products, in order to optimize ... worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more our company's… more
- Merck (Rahway, NJ)
- …The purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which ... with applicable regulatory requirements + Serving as regulatory labeling point of contact on global...Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA , also known as Merck Sharp & Dohme LLC,… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... _Develop,_ _Update and Execute_ _the Global Regulatory_ _Strategy_ _-_ _Initiate and Update Regulatory Strategy Document_ _(RSD)_ + Obtain input from the global … more
- Merck (North Wales, PA)
- …communicates regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling , Regulatory Chemistry, Manufacturing and ... all aspects of planning and implementation of a global regulatory strategy and regulatory submissions...Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA , also known as Merck Sharp & Dohme LLC,… more
- Merck (Rockville, MD)
- …The Director, Regulatory Affairs Liaison is responsible for:** + Developing regulatory strategy for their assigned products, in order to optimize label ... worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more our company's… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …within the BD Interventional Surgical Devices Business unit will work on regulatory strategy and submissions for Implantable and Absorbable devices. Under ... for regulatory submissions and compliance, including approval of product labeling , promotional, and advertising materials; review of clinical and human factors… more
- Amazon (Sunnyvale, CA)
- …in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, ... and driving proactive execution of a global regulatory strategy . They must enjoy problem solving...and product risk assessment. * Reviews and advises on labeling , product claims, marketing brochures, advertising and promotional material… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …possible** with us. **Key responsibilities will include:** + Responsible for the global regulatory strategy for BDB products. + Coordinates and advises the ... team and business objectives and deliverables are aligned with regulatory strategy and submission timelines. + Orchestrates...of regulatory submissions. + Serves as a regulatory expert for labeling and promotional materials… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …and new submissions, and RA leadership team representative. + Responsible for the global regulatory strategy for UCC products + Leads the RA function on assigned ... RA and other functions at project and upper management levels. + Provides regulatory strategy , risk evaluation and mitigation recommendations to project teams;… more
- J&J Family of Companies (Skillman, NJ)
- …support regulatory strategy for innovative projects across many regulatory classifications. + Labeling , digital, promotional review and approval, as well ... landscape, competitive benchmarking, external factors to help shape and inform regulatory strategy . * Demonstrate successful collaboration and partnership across… more
- Lilly (IN)
- …The Sr. Director, Regulatory Affairs will be responsible for directing regulatory strategy to support Akouos's programs across development stages, ranging ... programs in early- and late-stage clinical development. + Lead the development of regulatory strategies for assigned projects to advance Akouos products through the … more
- Philips (Plymouth, MN)
- …etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives. + ... assigned. + Review and approve advertising, promotional items and labeling for regulatory compliance. + Identify potential... approvals and submittal experience (EU MDR, Health Canada, USA (PMA, 510k). + Must be able to manage… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …taking on a lead role at the project level in developing and executing regulatory strategy and compliance plans to promote and support drug delivery solutions ... and/or approves product marketing claims and communication, Advertising/promotional materials, and labeling + Conduct trainings on regulatory issues for staff… more
- Teva Pharmaceuticals (West Chester, PA)
- …influencing the strategy and assessing the quality of documents for regulatory submissions to major market health authorities as well as coordinating with global ... process development, device development, analytical methods, formulation development, manufacturing, and labeling . The Sr Director, Regulatory Affairs CMC is… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in ... bold mission **OBJECTIVES:** + The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration… more
- Lilly (IN)
- …**About Loxo@Lilly:** Loxo@Lilly (L@L) conducts discovery research, clinical development, and regulatory affairs for oncology, with the goal of creating a pipeline ... Director, Clinical Supply Management has responsibility for the end to end strategy , specifications, on-time delivery, and management of the clinical trial material… more
- Lilly (Indianapolis, IN)
- …that clinical data generated for regulatory purposes meets all necessary regulatory standards. + Responsible for global registrations, labeling and label ... skills to facilitate cross-functional communication and decision-making across scientific, regulatory , and commercial stakeholders. **Responsibilities** The Associate Vice President-Medical… more
- Siemens (Grand Prairie, TX)
- …approach to safety, exceptional communication skills, and a deep understanding of regulatory compliance and best practices in industrial safety. **You will make an ... and maintain safety data sheets (SDS) and ensure proper labeling and handling of hazardous materials. + **Ergonomic Risk...on ergonomic best practices and proper body mechanics. + ** Regulatory Compliance:** + Stay current with OSHA, EPA, and… more
