- 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The role of Associate ... Director of US Commercial Regulatory Affairs requires the ability to apply...and subpart E and H submissions + Ensure full regulatory compliance of all promotions with approved labeling… 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
- Cardinal Health (Waukegan, IL)
- Cardinal Health is seeking a Senior Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will ... and the ideal candidate is located near Mansfield, MA or Waukegan, IL._** **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides … 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
- Medtronic (Minneapolis, MN)
- …a more connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST** In collaboration with leading clinicians, researchers, and ... provide. Therefore, we are looking for a passionate **Senior Regulatory Affairs Specialist** who has direct experience...ensure timely approval for market release. + Review significant regulatory issues with the manager as necessary,… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and export and labeling requirements, with some oversight from more senior regulatory specialist / manager .8. Participate in the training of more junior ... Position Summary:An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM)...on driving post-market changes (to include design, manufacturing, and labeling updates) through global regulatory approval processes.Key… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …Surgery Business Unit on implantable and absorbable devices. Under the mentorship of the Manager of Regulatory Affairs , the position will provide technical ... to register devices worldwide. + Review and approve product labeling , promotional, and advertising materials to ensure regulatory...with appropriate level of experience. + Minimum 1-2 years Regulatory Affairs experience in medical device or… more
- Danaher Corporation (Miami, FL)
- …Intern will gain hands-on experience and exposure in the critical area of regulatory labeling within the medical device and Life Sciences industry. Interns ... degree in a relevant field such as Technical Communication, Professional Writing, English, Regulatory Affairs , or a related discipline. . 0-2+ years experience… more
- Boehringer Ingelheim (Duluth, GA)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Manager , US Regulatory Affairs Operations is responsible for ... develop strategic approach for filing. + Prepares and submits regulatory submissions for activities such as labeling ...of which two (2) years to include interactions with regulatory authorities. + Regulatory Affairs … more
- J&J Family of Companies (Titusville, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... & Johnson Innovative Medicine R&D is recruiting for a Manager , Regulatory Scientist. This position is a...preferred. + A minimum of 4 years of relevant Regulatory Affairs experience in pharmaceutical, biotech or… more
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