- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... on regulatory strategy documents Supervise, review and approval of labeling for marketed products Track applications through FDA reviewing divisions Work with… 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 Supplies ... a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Catalent (Philadelphia, PA)
- …for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to ... over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel,… 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 ... (GL), and under the supervision of the Therapeutic Area Lead, the Regulatory Labeling Manager is responsible for supporting the facilitation and management… 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
- Gilead Sciences, Inc. (Boston, MA)
- … agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the oncology therapeutic ... therapeutic area. + Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the oncology therapeutic area.… 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 ... The GLL serves as the primary point of contact for Labeling Team members (eg Regulatory strategy leads, Safety Risk Lead, Clinical Development, Medical, and… more
- AbbVie (Irvine, CA)
- …and execute label change strategy for key label change projects, and labeling changes for early development, submission and production artwork to prioritize ... deliverables. + Comply with the labeling change schedule to meet established timelines. Communicate and...the creation of label artwork, mock ups utilized for regulatory submissions, and assist commercial, as required, in the… 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. ... to meet customer expectations regarding Quality. + Participates in regulatory and customer audits. This role may be for...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
- Amgen (Washington, DC)
- …your best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Affairs Manager - Regional Regulatory Lead** **Live** ... In this vital role you will achieve the desired labeling by developing and implementing US regulatory ...desired labeling by developing and implementing US regulatory strategies. **Responsibilities:** + Implement the US regulatory… 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...compliance with applicable regulations and standards governing the manufacturing, labeling , marketing, and distribution of our products. Your primary… 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...+ 1+ years regulatory experience in promotional labeling review and OPDP/CDER/FDA submission experience **BENEFITS** + Medical,… more
- Sanofi Group (Cambridge, MA)
- …the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling , product defense, and development projects. Serve ... promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as … more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , CMC Regulatory Affairs - West Chester, PA Date: Apr 24, 2024 Location: West Chester, United States, 19380 Company: Teva Pharmaceuticals Job Id: 54241 ... 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …compliant promotion and scientific engagement activities and review submission packages, labeling revisions, and promotional materials for regulatory compliance ... compliant promotion and scientific engagement activities and review submission packages, labeling revisions, and promotional materials for regulatory compliance.… more
- Stryker (Bloomington, MN)
- …products and solutions in a timely manner. We are currently seeking a ** Manager , Regulatory Affairs** to join our **Upper Extremities** **Division** based ... **Hybrid** in **Bloomington, Minnesota.** **What you will do** The Manager , Regulatory Affairs (RA) works with a high level of autonomy to oversee the … more
- Novo Nordisk (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- STERIS (Alpharetta, GA)
- Senior Manager , Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs Alpharetta, GA, US, 30004 Description: At STERIS, we help ... Utilizes electronic record-keeping tools according to departmental policy. The Senior Regulatory Affairs Manager is expected to have in-depth knowledge… more
- Magna (Troy, MI)
- Senior Manager , Regulatory Affairs Job Number: 61508...+ Right to Repair and Data Access + Safety Labeling (eg, New Car Assessment Program) + Measure and ... lead us on this journey. **Role Summary** **About the Role:** The Senior Manager , Regulatory Affairs assists with the development, evaluation, and execution of… more
