- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be ... of labeling documents according to internal SOPs and external regulatory requirements.Prepares submission-ready labeling documents; Maintains and tracks … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Manager , Regulatory Affairs Labeling position will provide ... Regulatory support for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved submitted and maintained for ... Participates on cross-functional teams focused on the planning and execution of regulatory labeling operations. This includes anticipating labeling … more
- Aequor (Northborough, MA)
- …group, located at the Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for ... outside contractors, vendors, internal auditors and representatives of various Regulatory agencies. Position Overview with Key Responsibilities: The candidate will… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Labeling Manager ** **What you will do** Let's do this. ... (GL), and under the supervision of the Therapeutic Area Lead, the Regulatory Labeling Manager is responsible for supporting the facilitation and management… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs Labeling position will provide ... Regulatory support for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling … more
- Boehringer Ingelheim (Ridgefield, CT)
- …Under supervision, the Fellow will: * Provide analysis, advice and guidance on US regulatory labeling strategies. * Research information on regulatory ... Regulatory Expertise: The Fellow will develop basic regulatory labeling expertise/knowledge in one or more...supplements initiated by BI, in conjunction with RA Product Labeling Management and the assigned RA Product Manager… more
- Integra LifeSciences (Princeton, NJ)
- … compliance, and cost management/process efficiency objectives. The Labeling Associate will collaborate with cross-functional teams, including Marketing, ... pathways to advance patient outcomes and set new standards of care. The Labeling Associate will assist with the execution and implementation of medical device … more
- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. The Labeling Associate - Design is responsible for creating, reviewing, approving, and maintaining ... finished goods labeling artwork and templates. This role requires an understanding...execution of end-to-end label implementation. Functional understanding of regional regulatory requirements is essential, ensuring compliance with FDA, MDR,… more
- AbbVie (North Chicago, IL)
- …in negotiating skills. + Strong interpersonal and organizational skills. + Understands Regulatory , Quality and Supply Chain aspects of labeling and impact ... has accountability for a team of Managers and Specialists within Global Labeling Operation. This includes responsibility for labeling operations for specific… more
- Danaher Corporation (Fargo, ND)
- … Manager , Operational QA, responsible for Developing and implementing labeling processes and procedures and collaborating with cross-functional teams, including ... Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align with regulatory requirements and company branding. In this role, you… more
- Abbott (Columbus, OH)
- …Work On** DESIGN/ART Delivers project excellence by incorporating best practices in labeling art production to meet and exceed customer needs through understanding ... nutrition product labeling requirements, including branding, FDA requirements, and regulations. Develops product labels that meet strategic, quality, budget, and… more
- HB Specialty Foods (Nampa, ID)
- … Regulatory Compliance Manager ensures all products meet US and Canadian regulatory labeling requirements. Job Duties: + Works with QA, Sales, R&D and ... Immediate Management Opportunity Regulatory Compliance Manager Salaried Job Summary:...reviews mock recalls. + Prepares finished good files for labeling . + Identify relevant guidance documents, international standards, or… more
- Olympus Corporation of the Americas (Westborough, MA)
- …ancillary labeling -related matters. Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling materials. Responsible ... @Olympus.com, it is likely not legitimate._ **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market Olympus medical devices in… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead** **Live** **What ... do** Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at Amgen ensures...In this vital role you will achieve the desired labeling by developing and implementing US regulatory … more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. The function of a ** Regulatory Affairs Manager , Advertising & Promotion** is to combine knowledge of ... of applicable product laws; Principles and requirements of promotion, advertising, and labeling . + Domestic and international regulatory guidelines, policies and… more
- Spectrum Plastics Master (Tucson, AZ)
- …under review. + Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance ... JOB PURPOSE: Provide management controls and ensure regulatory compliance requirements are met for all products...required in situations such as proposed device changes or labeling changes. + Coordinate efforts associated with the preparation… more
- AbbVie (Pleasanton, CA)
- …implements regulatory activities that support lifecycle management. * Reviews labeling and packaging components to ensure accuracy and compliance with government ... regulations. Submits product labeling in compliance with legal/ regulatory requirements and communicates planned/approved changes with operations, commercial,… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge...laws + Principles and requirements of promotion, advertising and labeling + Interpret and apply regulatory requirements.… more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage biotechnology ... Experts. **Salary:** $130,000-160,000/year **Workplace:** Onsite in Seattle, WA **Overview** The Manager , Regulatory Affairs (CMC) is responsible for providing … more
