- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC ... higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(EGP), in collaboration with Senior Medical Director Serve as NNI Medical Affairs representative on Medical & Science Team Review and provide comments to ... instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their ... Company and/or departmental expectations and goals as identified by senior management.Responsibilities- Lead drafting and negotiating contracts for commercial,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... to internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead/Director/ Senior Director - Safety Surveillance, US… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... brand/therapy area strategy and key decisions. US brand/therapy area representative across various NNI governance committees Omnichannel Experience Strategy: Provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and ...approve deliverables of the safety surveillance team Is safety representative in Trial Squad Plan, execute and drive all… more
- Allete (St. Paul, MN)
- Government Affairs Representative Senior Location St. Paul, MN Application Close Date 11/11/2024 Business Unit Minnesota Power Apply Now ... Maryland; and ALLETE Renewable Resources. Minnesota Power is seeking a talented Government Affairs Representative Senior with a strong background in state… more
- Medtronic (Lafayette, CO)
- …innovation in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for ... + Provide business and product information to the international regulatory affairs team to enable development and...within the Responsibilities section of this job description are representative of those that must be met by an… more
- United Therapeutics (Silver Spring, MD)
- …cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior ... submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising… more
- Medtronic (Los Angeles, CA)
- …a global leader in medical technology and solutions. Careers that Change Lives The Senior Regulatory Affairs (RA) Specialist - International will plan and ... compliance activities for International product approvals. + Develops and maintains regulatory affairs department procedures and process improvements. + Provide… more
- Abbott (Sylmar, CA)
- …Our location in Sylmar, CA currently has an on-site opportunity for a ** Senior Regulatory Affairs Specialist** with our Cardiac Rhythm Management ... reviews and approves change orders. + Acts as a regulatory representative on core product development teams,...attention to detail. **Preferred** **Qualifications** + Master's Degree in Regulatory Affairs and may be used in… more
- Integra LifeSciences (Harrisburg, PA)
- …with the Company's Notified Bodies and regulatory inquiries regarding regulatory issues/questions. + Maintains Regulatory Affairs product files ... and/or ability required for this position. + Bachelor's degree in science, Engineering, Regulatory Affairs , or other technically related field. + Minimum of 8… more
- Medtronic (Lafayette, CO)
- …**Must-Have: Minimum Requirements** + Bachelors degree + Minimum of 7 years of regulatory affairs experience with 5+ years of managerial experience, or advanced ... or performs coordination and preparation of document packages for regulatory submissions from all company areas, internal audits, and...within the Responsibilities section of this job description are representative of those that must be met by an… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory ... to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing...compliance and product expansion. + Acts as the company representative with regulatory authorities + Prepares and/or… more
- Drug Enforcement Administration (Arlington, VA)
- …the Administrator and serves as a close, confidential advisor to and representative of the Administrator on regulatory and administrative matters. ... legal, legislative, and policy matters of importance related to DEA's regulatory and administrative functions and create relevant briefing materials and analysis.… more
- Amazon (Sunnyvale, CA)
- …Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) ... the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to...medical products. Key job responsibilities * Acts as a regulatory representative on core product development teams,… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to ... **Essential Functions of the Job:** + Serve as the regulatory CMC representative on project teams. Provides...Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics… more
- Medtronic (Minneapolis, MN)
- …safely and efficiently, with more predictable procedure times and outcomes. The ** Senior Regulatory Affairs Specialist** develops strategies for worldwide ... Ablation Solution portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance...within the Responsibilities section of this job description are representative of those that must be met by an… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …skills. 7. Ability to comprehend technical documents and concepts. **External-Facing Title:** Senior Specialist Regulatory Affairs **Posting Country:** US - ... **12271BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for...development and operation teams, at times act as sole representative from Regulatory to ensure regulatory… more
- Conagra (Chicago, IL)
- …and commercial flights. As the ** Senior Food Safety Quality & Regulatory Affairs Specialist,** you will independently implement programs within the Contract ... We are looking for a ** Senior FSQRA Specialist (Contract Manufacturing)** to join our...technical support to appropriate functions and employees to assure regulatory compliance, food safety and quality. + Champions a… more
