- Aequor (Newbury Park, CA)
- …relevant issues to GRT Develop Regulatory Position with GRT Actively support regulatory compliance Support the development and execution of GRT goals ... of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards...Lead to manage GRT interactions The responsibilities of the Regulatory Affairs Senior Associate position are: Assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory ... works with ambiguity and complex problems, focusing on strategic and operational decisions.ResponsibilitiesActs as point of contact for cross-functional teams on… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director/Director, AR&D serves as Deputy ... Associate Director/Director, Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. (www.trispharma.com) is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position The Associate Director, HCP Experience has overall strategic and operational responsibility as well as tactical pull through of all efforts for Health ... to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare...the pharmaceutical industry including marketing, medical, access, public affairs, compliance , legal and regulatory as well as… more
- Merck & Co. (North Wales, PA)
- …of agency roles and process, and will maintain the highest level of compliance with regulatory requirements, and applicable laws and regulations. In addition, ... Job DescriptionWe are seeking an experienced, strategic, and results-oriented- Associate Director, Partnership Management-to support and drive our internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensures that material is fully released prior to shipment to siteEnsures compliance with all domestic and foreign regulatory requirements but may seek ... around rare diseases and immune disorders. SummaryThis is an operational position, task oriented in the execution of processes,...and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… more
- Genmab (Plainsboro, NJ)
- …and utilized at a pace never seen before. Join Genmab as an Associate Director, Solution Architecture and Engineering, R&D Digital Products as part of our ... ensure standards are met for test automation, quality, performance, security, and compliance .Stay current on leading practices and modern technology trends in the… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Durham, NC)
- …based on departmental budget and profit plan to address resource and operational challengesDecisions are guided by group or country strategies and policiesLeverages ... PEOPLE MANAGEMENT Leads Engineering & Maintenance team organization, including associate directors, coaches, technicians and engineers (30-40 people)Serves a… more
- Merck & Co. (North Wales, PA)
- …our company's biopharmaceutical business.This position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & ... and analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast spend related… more
