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Locum Head of Submissions & Author Service (MPAS) Please wait... Date Oct 4, 2022 Location Berlin, DE Heidelberg, DE Dordrecht, NL Pune, IN Beijing, CN New York, US London, GB Company Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals,
Posted 2 days ago
Directs or assists staff member(s) and independently reviews and approves content and required of promotional labeling materials for prescription drug and medical device products. Ensures that promotional labeling and training material meet regulatory and company requirements. The candidate must demonstrate a high level of understanding of promotion compliance and labelin
Posted Today
Tracking Code 15004 094 Job Description Job Title Senior Regulatory Operations Specialist About this role The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medic
Posted 5 days ago
- King of Prussia, PA / Norwalk, CT / New York, NY / 2 more...
In partnership with the VP, US Regulatory Affairs participate in the planning, development, and execution of regulatory strategies for document development, registration, and post marketing/authorization activities to support, including but not limited to initial BLAs/Marketing Authorization (MA) applications, INDs/CTAs, annual reports, briefing books, Scientific Advice r
Posted 7 days ago
Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state of the art biotechnologies to discover and deliver novel medicines in four areas of unmet need oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product develo
Posted 6 days ago
1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also focus on rare
Posted 1 day ago
Assist Director in the overall budgeting process Archive documents in a suitable manner as per SOP Provide project specific updates for weekly/monthly reports and presentations as needed Provide technical advice for projects involving partnership and due diligence Qualifications Education Preferred Bachelor degree or equivalent with 10 years' experience. Pharm.D., Master'
Posted 6 days ago
- New York, NY / Newark, NJ / Memphis, TN / 3 more...
The Senior Account Executive is a field based, direct sales role responsible for both client retention as well as growth through contract expansion and the introduction of new products and services. You will consult with C level executives to develop and implement an effective, enterprise wide strategy that maximizes the value delivered by Gartner's products and services.
Posted 14 days ago
Location Mountain Lakes, New JerseyUS Job ID JR 016948 Responsibilities Essential responsibilities include but are not limited to General Adhere to all company policies, procedures and comply with all safety & regulatory requirements. Monitor and measure metrics and present relevant data to the management. Ability to recognize issues and develop solutions for continuous i
Posted 17 days ago
Senior Manager CMC Writer Job Locations US NJ Paramus ID 2022 1747 Category CMC Type Regular Full Time Overview In the pharmaceutical industry and/or pharmaceutical development, broad knowledge and understanding of regulatory submissions, manufacturing processes, analytical methods, specifications, formulation development, test method validation, process validation, and p
Posted 20 days ago
Travere Therapeutics
- San Diego, CA / Denver, CO / Washington, DC / 14 more...
The Associate Director, Commercial Regulatory Affairs is responsible for labeling development and Regulatory advertising and promotion. As a member of the Commercial Regulatory Team, this person works closely with internal stakeholders to ensure that labeling and advertising/promotional activities are aligned with both internal strategies and regulatory guidance. This pos
Posted 8 days ago
Cosette Pharmaceuticals, Inc.
- South Plainfield, NJ
Represent Cosette Pharmaceuticals and lead and communicate on all regulatory issues involving the FDA and other regulatory health authorities for all products and businesses. Manage a team of regulatory professionals. Expertise in original ANDA/Post Approval Supplement and eCTD submissions. Responsible for planning and managing the preparation, submission and maintenance
Posted 24 days ago
This position supports the continuity and growth of Momentive businesses by leading a team responsible for Product Stewardship in the Americas region and related processes. Manages five employees plus contractors responsible for compliance with applicable regulations related to chemical management, products, and end use applications, product registrations to support busin
Posted 13 days ago
Leads the CMC function within Global Regulatory Affairs reporting into the Vice President, Global Head of Regulatory Affairs. Provides strategic leadership to support Otsuka's portfolio of investigational and marketed products for local and global filings. The candidate will be responsible for assuring development and execution of regulatory strategies for small molecule,
Posted 15 days ago
Provides strategic leadership to achieve the Company's mission and department goals, creating value for customers. Develops and implements strong customer focused business/marketing plans and establishes partnerships with customers. Builds new business through customer contacts and sales calls. Develops strong relationships with current and prospective clients needing reg
Posted 1 day ago
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