- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck (Upper Gwynedd, PA)
- **Job Description** The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory ... oversight model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: +… more
- STERIS (Pomaria, SC)
- …as assigned, under the guidance and direction of his/her manager and other senior Regulatory Affairs staff. General Duties + Responsible for maintaining ... Regulatory Affairs Intern Req ID: 43993...Key International Standards: + ISO 13485: Medical devices - Quality management systems + ISO 9001: Quality … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... affairs related to the development of novel therapeutics including quality , preclinical and clinical areas of drug development and the policies/procedures… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on...to ensure attainment of governmental approvals. + Responsible for quality and timeliness of IND/CTA and BLA submissions. Interact… more
- Astellas Pharma (Northbrook, IL)
- …should be elevated to upper management for further consideration. + Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that ... promotion review processes are compliant with approved company procedures. Represents Regulatory Affairs in cross-functional initiatives such as committees,… more
- Stryker (Allendale, NJ)
- …to apply? Here are 10 reasons to join our Regulatory Affairs / Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- ... is available at www.stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our **Spine Division** based **Hybrid**… more
- Stryker (Cary, IL)
- …to apply? Here are 10 reasons to join our Regulatory Affairs / Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- ... is available at www.stryker.com We are currently seeking a **Staff International Regulatory Affairs Specialist** to join our **Medical** **Division** based… more
- Cook Medical (Bloomington, IN)
- Overview The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA ... liaison to engineering functions globally and locally to provide technical support for Regulatory Affairs - Develop new, and refine existing, systems that provide… more
- System One (St. Joseph, MO)
- …+ MICROSOFT OFFICE + Strong proficiency in MS Office applications and Adobe Acrobat + General knowledge in relevant Regulatory Affairs areas. + General ... Title: Regulatory Affairs Specialist Location: St. Joseph,...guidance, the Specialist will be responsible to prepare high quality US regulatory submissions required by local… more
- Kelly Services (Beloit, WI)
- Kelly is seeking qualified candidates for a Regulatory Affairs Specialist to work at one of top clients in Beloit, WI. + Pay: $30/hr - $40/hr depending on ... knowledge. General knowledge of food drug regulations. Participates in regulatory related business projects as appropriate. Ability to make recommendations to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs . + Manager level: must have (1-3) years of experience in ... understanding of drug development, including phases of clinical studies, general requirements for drug marketing approval and basic statistics....the pharmaceutical industry, preferably in Regulatory or Medical Affairs . + Specific experience… more
- US Tech Solutions (St. Joseph, MO)
- …guidance and supervision, support systems for product compliance and maintenance. **Skills:** + General knowledge in relevant Regulatory Affairs areas. ... a part-time role (20 Hours/Week)** **Responsibilities:** + With minimum guidance, prepare high- quality US regulatory submissions required by local and federal… more
- Medtronic (Fridley, MN)
- …Have: Minimum Requirements** + Bachelor's degree required + Minimum of 2 years of regulatory affairs experience **Nice to Have** + Experience working in a ... Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards + Experience...project deadlines + Ability to work independently and under general direction only + Computer skills; MS Office, MS… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 7 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review… more
- Microsoft Corporation (Redmond, WA)
- …medical device, real world evidence, privacy, ethics, and responsible AI. The Scientific and Regulatory Affairs team of Health Futures is seeking a Healthcare ... endeavor to develop next-generation methods and tools for precision health. Health regulatory policy is dynamic and multi-faceted, requiring an understanding of new… more
- Highland General Hospital (Oakland, CA)
- …and compliant investigations. 5. Identifies growth and areas of opportunity to enhance Regulatory Affairs and AHS initiatives. 6. Identifies regulatory ... hospital operations or patient care experience; two years in accreditation/licensing/ regulatory compliance/ quality /performance improvement/patient safety in healthcare;… more
- Atlantic Health System (Morristown, NJ)
- Under the supervision of the Assistant General Counsel (ACG), review prepare and negotiate a full range of hospital contracts including, without limitation, ... ambulance agreements, and home health and hospice agreements, assuring legal and regulatory compliance. Serve as a primary resource for the interpretation of… more
- BeiGene (Emeryville, CA)
- ** General ** **Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects ... responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines… more
