- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required. Position can be based ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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
- Rose International (Temecula, CA)
- …an understanding of their impact on the systems environment. Responsibilities: * Labeling workstream project manager responsible for coordinating the creation, ... Hiring Organization: Rose International Position Number: 462447 Job Title: Associate Project Manager Job Location: Temecula, CA, USA, 92591 Work Model: Onsite Shift:… more
- Southeast Georgia Health System (Brunswick, 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
- 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
- Amgen (Washington, DC)
- …your best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Labeling Manager ** **Live** **What you will do** Let's ... under the supervision of the Therapeutic Area Lead, the Regulatory Labeling Manager is responsible...internal and/or external experts on the creation of high quality core labeling documents and manages the… more
- Astellas Pharma (Northbrook, IL)
- …to the Executive Director, CCDS and Labeling and sit on the labeling leadership team. In collaboration with strategic regulatory , this position will be ... ending labeling changes. This position will manage labeling content review and approval process applying regulatory...products. This position will also be responsible for ensuring quality documentation processes and QC of all labeling… more
- Bristol Myers Squibb (Summit, NJ)
- …proven ability to drive cross functional collaboration. + Understands Regulatory , Quality and Supply Chain aspects of labeling and impact of non-compliance. ... here at BMS with our Cell Therapy team. The ** Manager , Site Labeling Operations, MSAT MSEO** is...products, specifically regulations and standards affecting the Packaging and Labeling Quality System. **Basic Requirements:** + Bachelor's… 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
- Astellas Pharma (Northbrook, IL)
- …to the Executive Director, CCDS and Labeling , and sit on the labeling leadership team. In collaboration with strategic regulatory , this position will be ... ending labeling changes. This position will manage labeling content review and approval process applying regulatory...products. This position will also be responsible for ensuring quality documentation processes and QC of all labeling… 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
- Olympus Corporation of the Americas (Westborough, MA)
- …other ancillarylabeling-related matters. Work closely with Upstream Marketing and the Regulatory Labeling Team indeveloping labeling materials. Responsible ... by staying **True to Life.** **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs… 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
- 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
- Stryker (Cary, IL)
- …Here are 10 reasons to join our Regulatory Affairs/ Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... in a timely manner. We are currently seeking a ** Manager , Regulatory Affairs** to join our **Medical...clinical safety issues identified during clinical phases. + Provides regulatory guidance on strategy for proposed product claims/ labeling… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , CMC Regulatory Affairs - West... quality filing + Ability to assess technical quality of documents and to provide regulatory ... and new people to make a difference with. **How you'll spend your day** As Manager , CMC Regulatory Affairs you will be responsible for managing the day-to-day… more
- Abbott (Westford, MA)
- …stents. Our location in Westford MA, currently has an opportunity for a ** Regulatory Affairs Project Manager ** . As an individual contributor, the function ... of a Regulatory Affairs Project Manager is to combine...years of experience. + 2-5 years of experience in regulatory preferred but may consider quality assurance,… more
