- Aequor (Newbury Park, CA)
- …deliver training materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management & Systems documents Analysis ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...Partners as delineated in partnership/service agreements; maintains awareness of regulatory legislation pertaining to labeling and assesses… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....regulatory strategy documents Supervise, review and approval of labeling for marketed products Track applications through FDA reviewing… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical ... Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The primary responsibilities… more
- DivIHN Integration Inc (Green Oaks, IL)
- …2-3 years experience in a regulated industry (eg, medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research ... (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling ; Domestic and international regulatory guidelines, policies and… more
- Catalent (Philadelphia, PA)
- …Lead.Cross train with Quality Systems team by supporting activities of the Manager , Quality Systems which may include audit support activities, GMP training ... Coordinator. As a Training Coordinator, you will support the Training Program and Quality Systems. This position will assist in the development and maintenance of… more
- DivIHN Integration Inc (Alameda, CA)
- …to work 40hrs per week. Experience Background (Any): Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory ... CA Duration: 12 Months Job Description (Expectation) Responsible for regulatory activities, including product registrations, impact assessment, etc. Understand… more
- Ecovyst (Houston, TX)
- …departments. Responsibilities include, but are not limited to: Assist Operations Manager in hiring, training, and developing Operators & Loaders, promoting ... accountability culture on site.Work with Operations Manager to document hourly recognition and/or discipline.Oversee daily operations.Address current issues and… more
- Southeast Georgia Health System (St. Marys, GA)
- …guests, other team members, and medical staff by striving for excellence in service and quality . For our team members, this is more than a career - it's a calling. ... in diagnosis and treatment of disease. Participating in compliance of accreditation and regulatory standards (CAP, CLIA 88, GDHR) which relate to all areas of the… more
- AbbVie (Lake Bluff, IL)
- …guidelines, standards, etc. + Experience developing and implementing successful global regulatory labeling strategies. + Experience with InDesign a plus. ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination Products and… more
- Amgen (Washington, DC)
- … Labeling (GL), and under the supervision of the Therapeutic Area Lead, the Regulatory Labeling Manager will support oncology and is responsible for ... internal and/or external experts on the creation of high quality core labeling documents and manages the...functional teams to ensure that the implementation of global regulatory labeling plans are aligned with global… more
- Pfizer (San Diego County, CA)
- …external deadlines. The GLL serves as the GLM primary point of contact for Labeling Team members (eg Regulatory Strategist, Safety Risk Lead, Functional Line ... GLL serves as the primary point of contact for Labeling Team members (eg Regulatory strategy leads,...Pfizer Country Office (PCO) colleagues to support timely and quality submissions globally. + GLL represents the labeling… more
- AbbVie (Irvine, CA)
- …Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System. + Ability to logically reason, solve ... label change strategy for key label change projects, and labeling changes for early development, submission and production artwork...of 4 - 6 years combined experience from totals: Quality / Regulatory - 2 years, Operations - 2 years,… more
- Medtronic (Santa Ana, CA)
- …that labeling , art, film, and plate proofs meet all medical, legal, and regulatory requirements * Monitor changes in labeling regulations in the US and/or ... with the application * Monitor, evaluate and recommend improvements to labeling processes, quality , systems tools and/or policies Lead cross-functional… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Clinical Packaging and Labeling team is hiring! The Manager , QA is responsible for providing leadership and supporting direct reports within the QA Team. ... required processes, as needed, to meet customer expectations regarding Quality . + Participates in regulatory and customer...of years of experience for each level: + Associate Manager : 6+ years + Manager : 7+ years… more
- Bausch + Lomb (Rochester, NY)
- …and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices. + Ability to influence and ... to continue leading the advancement of eye health in the future. **Objectives:** The Regulatory Affairs Manager handles all regulatory development aspects of… more
- Walgreens (Deerfield, IL)
- …order to support achievement of key business objectives. This role ensures all regulatory considerations related to claims, product labeling and FDA requirements ... Equal Opportunity Employer, including disability/veterans". **Job ID:** 1394112BR **Title:** Manager , US Regulatory Affairs & Compliance **Company Indicator:**… more
- Kelly Services (Venice, FL)
- ** Regulatory Affairs Manager ** **Hybrid/Remote with up to 10-20% travel on site as needed** **Monday-Friday 8am-5pm, some hours outside of this time frame** ... **Position Overview:** As the Regulatory Affairs Manager , you will collaborate closely...13. ** Quality Assurance Collaboration:** 14. Collaborate with quality assurance teams to ensure adherence to regulatory… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Regulatory Manager , Advertising and Promotion? This position is located in our King ... Advanced degree in a Life Science + 1+ years regulatory experience in promotional labeling review and...Behring is a global leader in developing and delivering high- quality medicines that treat people with rare and serious… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …compliant promotion and scientific engagement activities and review submission packages, labeling revisions, and promotional materials for regulatory compliance ... levels if needed), in order to efficiently move documents towards final regulatory submission. Provides overall management, quality control (QC) and tracking… more
- FFP (Vista, CA)
- …and updating the company's product specifications and labeling information. + Support the Quality Manager and Regulatory Manager in customer audits ... compliance with regulatory requirements. This position will provide support to the Quality Manager and Regulatory Manager in implementing quality … more
