- Simplot (Boise, ID)
- …to promote the Regulatory Department and educate employees regarding regulatory affairs, license requirements, product registrations, and reporting. ... Director Product Regulatory and Compliance - Innvictis...into necessary process, technology, structural changes in order to support the needs of the business and regulatory… more
- Takeda Pharmaceuticals (Columbus, OH)
- …+ Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing ... my knowledge. **Job Description** **About the role:** **Associate Director, Nonclinical Regulatory Writing and Submission Support ,** **_Oncology and Marketed… more
- Adecco US, Inc. (Swiftwater, PA)
- …the site, including the update of CMC files. The incumbent is accountable for product license maintenance and site registrations. The incumbent also ensures the ... submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing...release by following submission and approval to ensure the product regulatory compliance on his/her sites(s) *… more
- Organon & Co. (Plymouth Meeting, PA)
- …and/or authoring of regulatory documentation. + Device and/or combination product regulatory experience. + Demonstrated superior oral and written ... sight to long-term robust supply. This role will directly support projects and/or coordinate with Regulatory CMC...of the changing regulatory environment. + Embed regulatory CMC activities within product development plans… more
- Medtronic (Lafayette, CO)
- …and supporting EU MDR implementation. The Sr. RAS role translates regulatory requirements into project/ product requirements and collaborates cross-functionally, ... assigned. + Provide strategic input and technical guidance on regulatory requirements for new technologies and product ...and communicate that information to the business team + Support international product registrations as needed +… more
- Abbott (St. Paul, MN)
- …with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry. **What You'll Work ... full working knowledge of GTS license types, country regulatory and language requirements. + Provide support for Product and Country Experts in the… more
- Merck (Columbus, OH)
- …compliance, and organizational efficiency. + Liaise with external partners, suppliers, and regulatory bodies to support product launches and lifecycle ... complex drug delivery systems. + Ensure adherence to quality standards and regulatory requirements throughout the product design, development, and manufacturing… more
- Teleflex (Morrisville, NC)
- …teams. * Interact and negotiate with regulatory agencies / Notified Bodies to support product life cycle management, including FDA for Class II and III ... and recommend solutions to address potential regulatory issues and impacts. * Support regulatory agency and/or notified body audits by as needed. *… more
- Merck (North Wales, PA)
- …leadership team as appropriate. + Provide regulatory leadership as needed in product in- license /due diligence review, product divestment and product ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises… more
- Organon & Co. (Jersey City, NJ)
- …and/or authoring of regulatory documentation. + Device and/or combination product regulatory experience. Professional Skills + Demonstrated oral and written ... include, but are not limited to: **Responsibilities** + Provide input to global product and project regulatory strategies by performing assessments of CMC… more
- Champion Pet Foods (Auburn, KY)
- …This position is required to assist with the preparation of QA and Regulatory documentation including facility audit, license renewals and maintain an accurate ... bank runs (eg, certified cheques, money orders, etc.) + Support Ingredient Management department in documenting and maintaining the... life cycle. + Update and maintain files in Regulatory SharePoint site, such as budget reports, product… more
- Organon & Co. (Plymouth Meeting, PA)
- …with a line of sight to long-term robust supply. This role will directly support projects and/or coordinate with Regulatory CMC scientists in the Organon ... and incorporating knowledge of the changing regulatory environment. + Embed regulatory CMC activities within product development plans that outlines the… more
- Globus Medical, Inc. (Audubon, PA)
- …and documents all related activates to remain in compliance + Demonstrates global regulatory expertise in product submissions and evaluates changes with local ... procedures and regulatory decisions for new or existing products + Reviews regulatory requirements from other departments for new product designs or changes… more
- Medtronic (North Haven, CT)
- …cross-functional teams, including R&D, Quality, Clinical, and Marketing, to drive regulatory submissions and maintain compliance throughout the product ... management. The initial project scope for this employee will be related to regulatory sustaining activities. New product development activities may be tied into… more
- Walmart (Bentonville, AR)
- …Manage and resolve regulatory investigations and enforcement actions. + Provide legal support for product recalls and other regulatory actions. + ... frameworks across a wide range of areas including product regulatory , food safety, alcohol, licensing &...and Leadership** + Develop and implement legal strategies to support business objectives while ensuring compliance with regulatory… more
- Merck (Philadelphia, PA)
- … Affairs and Clinical Safety (GRACS) and external to GRACS. + Develops worldwide product regulatory strategy to optimize label and obtain shortest time to ... as head of the Global Regulatory Team, which coordinates cross-functional regulatory support for development programs and marketed products. + Represents our… more
- Merck (North Wales, PA)
- …and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives. Serve ... and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages… more
- Lundbeck (Deerfield, IL)
- …cross functional partners and operational support . **ESSENTIAL FUNCTIONS:** + Provides regulatory review of product documentation intended for regulatory ... all drug development and approval aspects. + Manages the processing of regulatory submissions with Strategy leadership and operational support ; ensures… more
- Haleon (Warren, NJ)
- …and external. ** ** ** Role Responsibilities:** + Manage preparation of new regulatory strategies and documents for new product launches and maintenance of ... Haleon expectations + Support key processes and ways of working (eg, product labeling requirements, quality, local regulations) + Support the development of… more
- Teleflex (Chelmsford, MA)
- …during the development (ie Q-Sub, change notifications, etc.) and submission review. * Support regulatory agency and/or notified body audits by as needed. * ... and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory… more
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