- MetaOption, LLC (Jersey City, NJ)
- …regulatory trends, enforcement priorities, and compliance risks. + Support product lifecycle management, including submissions, labeling, and post-market ... Pharmaceutical Regulatory & Compliance Consultant Hiring Terms: Part-time We...ensure readiness for FDA inspections. + Manufacturing & Distribution Support + Provide guidance on facility design, validation, and… more
- Globus Medical, Inc. (Audubon, PA)
- …their lives as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs, is responsible for preparing, filing and gaining approval of 510(k), ... the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA...methods, and product knowledge, and maintains staffing needs to support all current and near term US filings. +… more
- Rhythm Pharmaceuticals (Boston, MA)
- …the designated program(s). The role encompasses overall accountability for shaping and steering regulatory direction to support program success. As the Global ... medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize… more
- TD Bank (Mount Laurel, NJ)
- … regulatory expectations and standards for effective compliance management systems + Knowledge of risk management environment, standards, and regulations + ... colleagues dedicated to setting new industry standards. The Compliance Regulatory Change Office (CRCO) Impact Assessment and Implementation Oversight Team… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …are implemented and sustained 3. Serve as a key point of contact to support regulatory activities, ensuring regulatory requirements are understood and ... reviews, ensuring completeness and accessibility **Crisis and Incident Management:** 1. Support regulatory response efforts during incidents and emergencies,… more
- Great Lakes Cheese (Hiram, OH)
- …dairy ingredients, and food packaging materials. * Collaborate with and provide regulatory support to cross-functional partners during innovation, renovation and ... & Risk Management network to ensure a cohesive, unified approach. * Support any regulatory initiative, including the creation, development, and maintenance… more
- Lundbeck (Deerfield, IL)
- … problems. + Ability to influence division management at all levels to support regulatory compliance needs. + Highly proficient in communicating strategic and ... functional support . + Liaises with CFTs to support labeling related Information requests from Regulatory ...to support labeling related Information requests from Regulatory bodies regarding label content and labeling change requests.… more
- PulteGroup (Coppell, TX)
- …on regulatory , procedural, and compliance matters. + Develop and maintain reporting systems for claims, curative actions, and operational support metrics. + ... + Mentor junior team members in claims, curative, compliance, licensing, and regulatory roles. + Support legal department initiatives, insurance audits, and… more
- Parexel (Harrisburg, PA)
- …to promotional activities. * Track and manage promotional submissions and approvals in regulatory systems * Manage SOPs and electronic review systems . ... CFR Part 202 and other relevant US regulations. * Support preparation of responses to regulatory inquiries...with strategic thinking. * Proficiency with Microsoft Office and regulatory systems (eg, Veeva PromoMats, eDMS). *… more
- Insight Global (St. Paul, MN)
- …assess business impact. * Coordinate data collection from internal teams to support regulatory submissions and regulatory reporting obligations. Cross ... Job Description Key Responsibilities Regulatory Compliance & Product Support *...and formulation changes. Documentation & Data Management * Maintain regulatory databases, internal systems , and document repositories… more