- Novo Nordisk Inc. (Plainsboro, NJ)
- …with decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines.… more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and...in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description: The RoleThe Senior Advisor of Regulatory Management will be responsible for supporting several critical regulatory filings, providing ... concise explanations in written and verbal communications, including to senior managementBroad familiarity with regulatory filings, operational, distribution,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed ... drugs for oncology indications. The Associate Vice President will manage and oversee the entire cycle of clinical development, including study design, initiation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior leadership to achieve global alignment on all technical Carvykti ... and external CMO sitesDrive new process version plans and content for regulatory submissionsEnsure global records are consistent and maintained to achieve… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... excellence in the late development of ophthalmology assets.May serve as a senior therapeutic area content expert within the company, providing input into research… more
- Merck & Co. (Washington, DC)
- …Director, Policy Advocacy The Associate Director, Policy Advocacy serves as the senior expert in the Global Public Policy (GPP) organization on designing and ... change in support of the company's business objectives. The Associate Director will proactively research and stay abreast of...and use their deep expertise in leading and managing global to local policy advocacy campaigns to create a… more
- Merck & Co. (North Wales, PA)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… more
- Merck & Co. (Durham, NC)
- …the above-listed Quality Systems to ensure compliance with all global and regulatory standards. Develops and report to senior leadership data analysis and ... Job Description- The Associate Director of Quality Systems provides leadership, focus,...systems and aligned with strategic direction defined by the global business model and regulatory agencies.- The… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Instrumentation Technician (O3) The Senior Maintenance Technician is responsible for providing equipment ... systems)Required Experience and Skills: Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations Preferred… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director, Policy Strategy and Capabilities The Associate Director, Policy Strategy and Capabilities is ... team, reporting to the Executive Director, Policy Development & Strategy.The Associate Director will develop and maintain the strategic planning digital platform,… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Merck & Co. (North Wales, PA)
- …is based out of Upper Gwynedd, PA, reporting directly to the Associate Director, US Vaccine Portfolio Marketing Strategy & Implementation Lead.- Responsibilities ... Review Team (PRT) approvals, and production.Maintains working knowledge of regulatory guidance & delivers compliant programs.Manages creation and monitoring of… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director, Alliance Management.Tris Pharma has a long track record of successful ... alliances, from global commercial partnerships to R&D collaborations to manufacturing/distribution partnerships....departments across all stages of the product lifecycle. The Associate Director, Alliance Management will be accountable for managing… more
- Fidelity TalentSource LLC (Westlake, TX)
- …and Planning, Employee Compliance, Workplace Solutions Compliance, Advice Solutions Compliance, Regulatory Compliance, Global Sanctions and Risk Assessment and ... Job Description:The Role The Senior Manager, Business Analyst is part of a...Skills You BringBachelor s degree requiredPrevious project management, audit, regulatory , risk or compliance environment experience required8+ years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Fidelity TalentSource LLC (Merrimack, NH)
- Job Description:The Team The Fidelity Global Security and Technology Group is seeking a motivated Senior Systems Engineer who has experience delivering creative ... within a collaborative, fast-paced environment. Our team is passionate about Global Security and Investigation's Mission - "Protect Fidelity's assets: our… more
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