- Parexel (Nashville, TN)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs ... professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior … more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- This position with the Regeneron Regulatory and Commercial Law team will provide proactive and collaborative legal advice and counsel in connection with the ... advisor to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. Counsel will advise… more
- Medtronic (Minneapolis, MN)
- …dynamic and fast-paced environment. This position reports to the Senior Program Manager- FDA /Life Sciences, Enterprise Legal Regulatory . This will be an onsite ... **A Day in the Life** Medtronic is seeking an FDA /Life Sciences paralegal as a member of the Enterprise...Sciences paralegal as a member of the Enterprise Legal Regulatory (ELR) team with knowledge and experience navigating requirements… more
- MetaOption, LLC (Jersey City, NJ)
- …a focus on manufacturing and wholesale distribution. + Proven track record in FDA regulatory compliance, including cGMP, GDP, and DSCSA. + Experience working ... adherence to regulatory standards. Key Responsibilities + Regulatory Compliance Oversight + Advise on FDA ,...+ Regulatory Compliance Oversight + Advise on FDA , DEA, and state regulatory requirements for… more
- Chiesi (Cary, NC)
- …regulatory affairs, FDA regulations, or drug development. + Familiarity with FDA regulatory pathways (eg, IND, NDA, BLA, orphan drug designation). + ... responses to FDA information requests). + Conducting background research on FDA regulations, guidance, and regulatory precedents relevant to rare diseases… more
- ITG Brands (NC)
- …tobacco and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and ... regulatory industry (tobacco, pharmaceuticals, medical devices). + Strong background in FDA regulatory matters, state- regulatory compliance, regulatory… more
- GRAIL (Albany, NY)
- …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Xcelerate Solutions (Frederick, MD)
- …trend knowledge points and risks through the medical portfolio + Track and trend FDA regulatory intelligence + Assist with full lifecycle project management and ... Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking...for pharmaceutical development and within the constraints of the FDA approval process + Plan and provide input to… more
- Unilever (Austin, TX)
- …CFR Parts 111 and 117. The position will also serve as the primary liaison with regulatory agencies such as the FDA and FTC. In addition to managing day-to-day ... issues as necessary. + Conduct internal audits and support third-party, FDA , and regulatory inspections. + Generate and analyze quality KPIs and trends and… more
- Dentsply Sirona (Waltham, MA)
- …device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of FDA 510(k) and international ... + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. + Ability to work… more