- Parexel (Columbia, SC)
- …in a matrix organization. - Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. - Experience with flu campaigns, pandemic products, ... Join us as a **Global Labeling Operations Manager ** , where you'll...years of biotech/pharma industry experience, including 2+ years in labeling / regulatory operations with global responsibility. - Experience… more
- CSL Behring (King Of Prussia, PA)
- …of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... provides Medical Safety review and approval for PMS documentation, labeling /IFU creation, Clinical Evaluation Reports, developing responses to inquiries from… more
- Lundbeck (Deerfield, IL)
- …ordering systems, tracking, and reporting. Additionally, in partnership with Regulatory Affairs , Promotional Review Committees (PRC/MLR), and Marketing, ... degree + 2 years of experience in Biotech, Medical Device or Pharmaceutical regulatory operations, regulatory affairs , marketing operations, or promotional… more
- AbbVie (Irvine, CA)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and ... changes and process the labeling in accordance with internal labeling procedures. + Maintain documentation within regulatory information management system.… more
- Parexel (Des Moines, IA)
- …in a matrix organization. * Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management. * Experience with flu campaigns, pandemic products, ... Join us as a **Global Labeling Operations Manager ** , where you'll...years of biotech/pharma industry experience, including 2+ years in labeling / regulatory operations with global responsibility. * Experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be ... regulatory and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU … more
- Chiesi (Boston, MA)
- …Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... changes to existing labeling , and submission of labeling information to regulatory authorities in the...product risks are appropriately communicated. + Provide training to Regulatory Affairs and other departments as appropriate.… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function ... and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …local market authorization holders and distributors. **Primary Responsibilities:** + Act as Regulatory Affairs authority for key product registrations with a ... required for registration and routine product shipments. + Evaluate impact of new labeling regulatory requirements as well as evaluate changes to existing… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...with product post marketing approval requirements + Review product labeling and promotional materials to ensure compliance with relevant… more
- Coty (Morris Plains, NJ)
- Senior Manager , US Regulatory Affairs and Ingredient Support **SENIOR MANAGER , US REGULATORY AFFAIRS AND INGREDIENT SUPPORT** **COTY is looking ... of expressing their beauty, their way.** As the **Senior Manager of US Regulatory and Ingredient Support,**...and defense. This position reports to the Director, NA Regulatory Affairs and R&D Material Management and… more
- Stryker (Mahwah, NJ)
- **Senior Manager , Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager , Regulatory Affairs ... new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... cleared products or systems and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory oversight of changes in… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to...laws + Principles and requirements of promotion, advertising and labeling + Interpret and apply regulatory requirements.… more
- Abbott (Lake Forest, IL)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** The **Sr. Regulatory Affairs Manager ** hired in this role will work ... providing lab results for millions of people. **What you will do** Provide regulatory affairs project management for various areas, to include 510(k), CLIA… more
- Boehringer Ingelheim (Ridgefield, CT)
- …field with eight to ten (8-10) years' experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required OR Master's degree with a ... labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager...six (6) years' experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required. +… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling ,...global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory operations, etc.) to… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …but not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they are responsible for the development ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the...synchronize domestic and international submissions. + Review and Approve Labeling and Advertising and Promotional materials for compliance to… more
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