- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... globally, coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative… more
- Lundbeck (Deerfield, IL)
- …problems. + Ability to influence division management at all levels to support regulatory compliance needs. + Highly proficient in communicating strategic and ... Director US Regulatory Global Strategic Labelling...lifecycle management.Serves as a reviewer/Deputy Chair for the Lundbeck Product Labelling Committee (LPLC) and related labelling compliance… more
- Repligen (Waltham, MA)
- …and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you ... efficiency, and enabling innovation across the bioprocessing manufacturing and product development lifecycle.This position requires strong collaboration with business… more
- SMBC (Jersey City, NJ)
- …+ Lead and contribute to large-scale, cross-functional projects to enhance regulatory compliance infrastructure. + Develop and deliver training materials ... portfolio of benefits to its employees. **Overview** As a Regulatory Policy Director at SMBC you will...in industry forums to discuss capital, liquidity, and other regulatory topics. **Technical Advisory & Product Analysis**… more
- Post Holdings Inc. (Lakeville, MN)
- …about pet nutrition and regulatory excellence? Join our team as the **Associate Director of Pet Food Regulatory Affairs** , where you'll lead a talented team ... and shape the future of pet food compliance , labeling, and product claims. This is...professionals, driving excellence in pet food labeling, advertising, and product registration. + Serve as the **go-to regulatory… more
- GRAIL (Carson City, NV)
- …labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on international ... with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material… more
- Novo Nordisk Inc. (Boulder, CO)
- …programs to ensure product safety and quality Responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of ... Assurance (QA) function and serves as the leading expert in quality, compliance , and quality management systems (QMS). Provide direction & coordinate the Quality… more
- Insmed Incorporated (NJ)
- …risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments, ... company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) ... years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval… more
- WCG Clinical (Raleigh, NC)
- Data Analytics & Insights (DAI) Product Solutions, Associate Director (Remote) **General Information** **Location:** Cary, NC, Remote **Organization:** ... qualifications, experience, skills, education, and geographic location. **JOB SUMMARY:** The DAI Product Solutions Associate Director is a key leader responsible… more
- Genmab (NJ)
- …and adherence to corporate complianceCurrent working knowledge of US-specific legal, regulatory , and compliance regulations and guidelines relevant to industry ... fit? Then we would love to have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an… more
- Formation Bio (New York, NY)
- … vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- SMBC (New York, NY)
- …**Role Description** **Overview** We are seeking an experienced and strategic **Executive Director ** to lead the **Payables and Receivables** product portfolio ... to deliver scalable, client-centric solutions that meet evolving market and regulatory demands. + Oversee product lifecycle management, including ideation,… more
- WCG Clinical (Raleigh, NC)
- Senior Director , Product Management & Strategy (Remote) **General Information** **Location:** Cary, NC, Remote **Organization:** WCG **Job Type:** Full Time - ... experience, skills, education, and geographic location. **JOB SUMMARY:** The Senior Director , Product Management & Strategy is a leadership position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ultimately negotiated with assigned accounts. Relationships Reports to the Executive Director / Director on the Strategic Pricing and Contracting team. Works ... Rare Disease), as well as with internal stakeholders (Government Contracts & Compliance , Rebate Operations and Insights, Market Access Strategy, Legal, and others).… more
- Merck & Co. (North Wales, PA)
- Job DescriptionAssociate Director US Marketing, HCP Strategy - OphthalmologyOur company is dedicated to delivering innovations that extend and improve the lives of ... (nAMD), and retinal vein occlusion (RVO)).-We are currently recruiting for an Associate Director US Marketing, HCP Strategy - Ophthalmology. This is an exciting time… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
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