- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... Immunochemistry, People Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design of… more
- Merck & Co. (Upper Gwynedd, PA)
- …all assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for ... products and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory… more
- Merck & Co. (Rahway, NJ)
- …collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to ... Job DescriptionJob Summary: -The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization.… more
- Masters Gallery Foods (Plymouth, WI)
- …and start where you can grow, you can at Masters Gallery Foods. Join us! Product Development & Regulatory Compliance Manager As the Product Development & ... and Production. Assist in scale up to commercialization. Review existing product line to ensure continuous accuracy. Work closely with Graphics Department… more
- eBay, Inc. (Austin, TX)
- …obsess over building best-in-class experiences that our eBay community loves. As a Sr. Product Manager on eBay's Regulatory team, you will be responsible for the ... communities. It's really easy to build point solutions for regulatory requirements - your job is to ensure we...integrity and having fun! What you will accomplish: Create Product Strategy & Vision - You will be responsible… more
- Twist BioScience (South San Francisco, CA)
- … product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll Be Doing Initiate, ... The Regulatory Operations Specialist is responsible for ensuring the...with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP's. This role is crucial in… more
- Merck & Co. (Rahway, NJ)
- …members of GRACS Leadership Team to provide guidance on the application of regulatory activities with cross- product or cross-functional impact, including drug ... to regulatory strategies that accelerate and maintain access of product through market authorization, execute of post marketing commitments and meet compliance… more
- Merck & Co. (Rahway, NJ)
- …Innovation, Mentoring Staff, Operating Models, People Leadership, Pharmaceutical Development, Product Design, Product Development, Regulatory CMC, ... and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice (cGMP)… more
- Merck & Co. (Rahway, NJ)
- …global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirementsActively participate in ... of CAPA implementation and effectiveness to ensure no recurrence of findingsGather regulatory intelligence and partner with our Company and CMO management to prepare… more
- Twist BioScience (South San Francisco, CA)
- …reports by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 ... processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this position you will report… more
- Twist BioScience (South San Francisco, CA)
- …System (ISMS) standards in the execution of their daily activities and ensuring product or service meets regulatory requirements, customer requirements and the ... field-based sales team. The position will specifically support Twist's current product lines consisting of synthetic genes, oligo pools, and DNA libraries.What… more
- Eisai, Inc (Nutley, NJ)
- …manages a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as life ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the...regulatory representative on the project team throughout the product lifecycle. Provide senior staff advice and guidance on… more
- Pall (Miami, FL)
- …for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the ... and Beverage applications. Responsible for ensuring product meets all product claims specifications and regulatory requirements throughout the product… more
- Merck & Co. (Rahway, NJ)
- …understanding of medical device assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding ... robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to develop… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Product Security Lead Designer, you will play a pivotal role in shaping the security landscape of our organization. Your primary ... DevSecOps, ), ensuring alignment with industry best practices and regulatory requirements.Collaborating with Cross-Functional Teams: Work closely with engineering, … more
- Pyramid Consulting, Inc. (Houston, TX)
- … product backlog, prioritizing features based on client needs, regulatory compliance, and business goals. Collaborate with cross-functional teams including ... with regulatory standards (eg, FINRA, SEC) Gather and prioritize product requirements from internal stakeholders and clients. Prepare and deliver training, … more
- Merck & Co. (North Wales, PA)
- …Integration, Operational Excellence, Oral Communications, Pharmaceutical Management, Product Registrations, Professional Networking, Project Management, ... including pipeline candidates and licensed products. The Section Head manages Product Development Team (PDT) leaders and clinical directors responsible for the… more
- Eisai, Inc (Nutley, NJ)
- …orientation to identify breakthrough opportunities.Comprehensive understanding of legal and regulatory issues impacting pharmaceutical product marketing as well ... project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise and input… more
- EPM Scientific (Philadelphia, PA)
- …to join a cutting-edge organization and play a key role in shaping regulatory strategy and supporting innovative product development. The Regulatory ... input Develop and maintain procedures and work instructions to ensure ongoing regulatory compliance Collaborate closely with product development teams to… more
- Cleerly (Denver, CO)
- …the Opportunity As Principal Regulatory Affairs Specialist, you will provide regulatory support and strategy development for product development from early ... and review and advise on labeling to ensure compliance with regulatory filings. Review product changes for impact on regulatory filings worldwide and… more
