- Merck & Co. (Rahway, NJ)
- …Regulatory Affairs, R&D, Manufacturing and GHH management teams, product development teams, and executive management.Establishes strong cross-functional and ... requirements are met and that systems are used appropriately to ensure proper product control. Ensures appropriate reviews, approvals and systems are in place… more
- Insmed Incorporated (NJ)
- …that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function, RA CMC is ... device combination product development at various development stages and product lifecycle management.Stay current with regulatory guidelines and industry… more
- AUROBINDO (Dayton, OH)
- …company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of ... products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Building and Environment monitoring team to ensure the facility is in a state of control and update / communicate with all teams with any emergencies and ... clean space walkthroughs to ensure GMP compliance.Actively participate in all regulatory and internal audits of the facility.Participate in the hiring, development,… more
- CVS Health (Raleigh, NC)
- …every day. **Position Summary** Responsible for researching, analyzing and interpreting state regulatory requirements, developing and drafting state -specific ... Develop, draft, submit and negotiate timely approval of high-quality regulatory filings that comply with state and...regulators. - Provide timely follow-up and response. - Negotiate regulatory objections. - Obtain regulatory approvals… more
- Medtronic (Lafayette, CO)
- …office. Relocation assistance is available for qualifying candidates. **Responsibilities** ** Regulatory Strategy & Product Development:** Develop and implement ... global regulatory strategies to support the entire product lifecycle, from R&D through to commercialization and post-market activities. Partner with R&D,… more
- Medtronic (Mounds View, MN)
- …**Principal Regulatory Affairs Specialist** will provide strategic leadership for regulatory affairs in support of new product development and introduction ... as they arise. **Role and Responsibilities** + Develop and execute global regulatory strategies for new product development and introduction, including… more
- Danaher Corporation (Boston, MA)
- …Files, STED), including documentation, timelines, and agency interactions to secure product approvals . + Collaborate cross-functionally and globally with ... on key projects, engaging with global regulatory agencies, and steering regulatory strategy for new product development and strategic initiatives. By guiding… more
- Medtronic (Lafayette, CO)
- …**Key Responsibilities:** + Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering ... approvals , license renewals, and annual domestic and international product registrations. + Recommends changes to labeling, manufacturing processes, marketing… more
- GRAIL (MD)
- …with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material ... member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies. + Provide regulatory support for both new and… more
- Fujifilm (College Station, TX)
- …manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for marketing products manufactured ... as applicable. + Provide continuing regulatory education and disseminate regulatory information to the product development, marketing, and clinical groups.… more
- J&J Family of Companies (Danvers, MA)
- … partners in preparing submissions for global expansion. + Assist in obtaining product approvals and monitor the progress of submissions. + Maintenance of ... recovery. **You will be responsible for** : + Prepare and submit regulatory documents, including applications for product registrations, amendments, annual… more
- Terumo Aortic (Sunrise, FL)
- …to ensure compliance with corporate procedures and timely product approvals with domestic and international regulatory requirements. POSITION IN ORGANISATION ... by other departments. + Partner with cross functional teams by providing preliminary regulatory guidance and support to product development teams for strategic… more
- Kemin Industries (Des Moines, IA)
- …for Kemin products deemed necessary to achieve business outcomes such as global regulatory approvals and clearance for Kemin Health ingredients, labels, and ... priorities of the business. This individual will be responsible for overseeing product compliance and registrations at state , national, and international levels.… more
- Takeda Pharmaceuticals (Boston, MA)
- …years regulatory and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU ... life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development… more
- Haleon (Warren, NJ)
- …+ Ensures cross portfolio aligned regulatory strategy to deliver timely approvals for US submissions and OTC Monograph product launches. + Develop ... and implement regulatory strategies and documents for new product launches and maintenance of current products aligned with the regulations. + Manage compliance… more
- Schwan's Company (Minneapolis, MN)
- …Planning, and R&D teams to provide regulatory expertise for new product launches, specification approvals , ingredient compliance, packaging innovations, and ... a key regulatory expert, and manage complex compliance programs including product safety, labeling, import/export, and crisis management. If you thrive in a… more
- AbbVie (North Chicago, IL)
- …and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand ... focused on small molecule products in development. Responsibilities: + Prepares CMC regulatory product strategies. Prepares and manages regulatory … more
- Edwards Lifesciences (Irvine, CA)
- …impact of proposed and current global regulations and proposing suggestions for expediting approvals + Assist Business Unit Regulatory Affairs & Functional teams ... high risk (ie Class III) devices + Good knowledge and understanding of global Regulatory requirements for new products or product changes + Good knowledge of… more
- Amazon (San Francisco, CA)
- …agencies, and regulatory authorities to manage testing, documentation, and product approvals - Lead debugging, root cause analysis, and corrective ... needs for customers and businesses across the globe. The Sr. HW Regulatory Compliance engineer ensures that our products meet all relevant regulations. This… more
