- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory Compliance : Ensures compliance with all Federal regulations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at...in Patient Safety including, but not limited to contract review and vendor management support in regard to safety… more
- HSBC (New York, NY)
- …development and continuous review for appropriateness of control framework to monitor Regulatory Compliance risk developments impacting on IWPB in the US + ... Director of Wealth, Private Banking and Insurance Regulatory Compliance Brand: HSBC Area of...ensure that suitable processes are put in place to review and oversee that internal control environment against those… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure departmental KPIs and regulatory compliance are consistently met Implement Medical Review Prospective & Retrospective Quality Review of cases ... About the Department The Clinical, Medical and Regulatory (CMR) department at...Director is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... solving and issue resolution, etc.Develop risk mitigation plans for key partnersProvide regulatory review of documentation prepared by other technical functions… more
- Insmed Incorporated (NJ)
- …CMC meetings with the regulatory agencies, and draft and review regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO ... global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all pertinent regulations and guidance documents for pre- and… more
- BeOne Medicines (Emeryville, CA)
- …commercial, clinical development, medical affairs, patient safety, legal, and healthcare compliance . + Review and provide guidance on a wide range of ... with some activity globally. This role supports our commercial, medical affairs, legal, healthcare compliance and other...guidelines. **Essential Functions of the job:** + Oversees the regulatory review process for promotional materials in… more
- Terumo Aortic (Sunrise, FL)
- …and activities may change at any time with or without notice. Support for the regulatory side of the business to ensure compliance with corporate procedures and ... the preparation of US, EU, and rest of world regulatory submissions as required. + Review proposed...college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5… more
- Terumo Neuro (Aliso Viejo, CA)
- … regulatory approvals. + Review promotional material and labeling for regulatory compliance . + Develop and maintain regulatory files and records. ... for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency...assigned projects and develop approaches to solutions. + Coach, review , and delegate work to junior regulatory … more
- ITG Brands (Greensboro, NC)
- …(tobacco, pharmaceuticals, medical devices). + Strong background in FDA regulatory matters, state- regulatory compliance , regulatory litigation, ... the Company)_ Key Responsibilities Provide expert legal counsel on federal and state regulatory compliance , with a focus on tobacco and nicotine products. Serve… more
- Teleflex (Morrisville, NC)
- …development to launch for moderate-complexity projects and ensure appropriate data collection for regulatory submissions and compliance . - Review and assess ... change control activities for potential impact on current regulatory filings. - Ensures compliance with design...and contingency planning for assigned projects. - Interact with regulatory authorities during the development and review … more
