- 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
- 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
- TikTok (San Jose, CA)
- …Share this listing: Responsibilities About the team The TikTok Privacy & Responsibility Product division's goal is to meet all of our privacy, responsibility and ... create, and enjoy content on TikTok.Responsibilities - Lead global product compliance for all new and emerging laws, ensuring...strategically with legal and policy teams to identify critical regulatory themes and assess their impact on our users.… 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
- AstraZeneca (Gaithersburg, MD)
- …the product 's life cycle. Drive and lead delivery-focused teams, eg, GRET (Global Regulatory Execution Team) on a product level or RSDT ( Regulatory ... special designations used during development, authorizations, and extension of the product . Identify regulatory risks, opportunities, and proactively develop… more
- BioSpace (Indianapolis, IN)
- …requirements and guidelines for reporting post approval changes and updating global product registrations. Develop and evaluate global CMC regulatory strategies ... extensions or renewals, and responses to questions. Make decisions on CMC regulatory strategies impacting product submissions across geographies and networks for… more
- Citigroup, Inc. (Getzville, NY)
- Regulatory Operations Vice President (VP) will be responsible for NAM cross- product Regulatory Reporting and Controls covering key OTC derivative reporting ... candidate would have a combination of several of the following: Product Knowledge: Extensive Regulatory and/or Derivative product knowledge from at least one… more
- Fate Therapeutics, Inc. (San Diego, CA)
- …regulatory leadership for due diligence activities, partnering activities, and product /company integrations. Provide mentorship and oversight of Regulatory ... for pivotal / registrational studies is highly preferred. Previous cell therapy product experience and regulatory knowledge is highly preferred. Prior direct… more
- Central Garden & Pet (Dallas, TX)
- …applicable products, as appropriate Assist New Product Development in working through regulatory product approval processes in the US and overseas Support ... opportunity for a skilled and experienced Food Safety and Regulatory Affairs (FSRA) Manager to join our team! This...team! This position reports to the Sr. Director, FDA Regulatory Affairs & Food Safety and will support all… more
- BioSpace (Boston, MA)
- …Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product -specific Global Regulatory Teams (GRTs) and representing the ... Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific value evidence topics, as… more
