- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Global Regulatory Labeling , Policy and Intelligence Associate Director will primarily be ... of labeling documents according to internal SOPs and external regulatory requirements.Prepare submission-ready labeling documents; Maintain and track … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... teams accelerate progress. The Associate Director, Global Regulatory Affairs - Global Labeling Strategy is...function. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements, particularly US and EU.… more
- Gilead Sciences, Inc. (Foster City, CA)
- … agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic ... indications. + Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area. + Provides… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- ManpowerGroup (Santa Clara, CA)
- …Acrobat Pro, SAP MD, and content management tools + Familiarity with international regulatory labeling requirements + Background in regulatory documentation, ... Clara, CA. This is a **6-month contract role** responsible for managing regulatory submissions and international labeling requirements for Class III implantable… more
- Bausch Health (Bridgewater, NJ)
- …policies and guidance and correctly apply them as appropriate in product development and labeling regulatory + Regulatory Affairs Certification by RAPS a ... itwhere your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director, US Advertising & Promotion Regulatory (A&P Excellence)** **Takeda ... Pharmaceutical** **USA-MA-Virtual** **About the role:** Join Takeda as an Associate Director, US Advertising & Promotion Regulatory (A&P Excellence) where you… more
- Boehringer Ingelheim (St. Joseph, MO)
- …such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will...technical input for Freedom of Information Summary and product labeling for assigned projects. + Works in project teams… more
- ADM (Erlanger, KY)
- **97854BR** **Job Title:** Associate Regulatory Specialist - Erlanger, KY **Department/Function:** Legal, Compliance, Regulatory Affairs, Corporate Security ... **Job Description:** ** Associate Regulatory Specialist - Erlanger, KY** **MAIN FUNCTION:** This entry...of vendor documentation and other sources of raw material regulatory data + Food and flavor labeling … more
- Wellness Pet Company (Burlington, MA)
- …the packaging review and approval process to ensure accuracy and compliance with regulatory labeling standards. + Review marketing copy, product claims and ... Regulatory Affairs Associate Department: Regulatory ...website content for accuracy, and compliance with regulatory labeling standards. + Research export requirements… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director, Regulatory Data Governance Lead **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking an Associate Director, Regulatory Data Governance Lead with...of data related to the drug development lifecycle, including regulatory submissions, labeling , and product tracking; Oversee… more
- Newell Brands (Huntersville, NC)
- …collaborative environment where you can be your best, every day. **_Summary:_** The Associate Regulatory Specialist / Engineer will be responsible for ensuring ... product safety and regulatory compliance in all countries where our products are...and develop mitigation plans. + Review and approve product labeling , packaging artwork, and instruction booklets to ensure safety… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work on-site at ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific)...preclinical, clinical and manufacturing charges. + Review and approve labeling to ensure compliance. + Represent regulatory … more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs** , works out of our ... (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs. We're empowering smarter medical and economic decision-making to help transform… more
- Cargill (Wichita, KS)
- …around the world and connect with something greater. **Food Safety, Quality, and Regulatory Associate Position:** The purpose of this position is to develop ... if your ideas could nourish the world? As an associate , we transfer your knowledge and skills into profound...of increased complexity across the Food Safety, Quality, and Regulatory (FSQR) job family at various locations across Cargill.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …your best self. Become a **maker of possible** with us. **Job Overview** The Associate Director of Regulatory Affairs will provide regulatory support for ... activities, developing and maintaining documentation for compliance programs such as labeling , promotional material review, and other regulatory requirements.… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Sarasota, FL)
- …customers. The Regulatory Compliance Specialist also provides support to the Labeling Department for label review and approval, as well as reviews of marketing ... and launches new document requests as needed to support labeling claims or new regulatory requirements. +...associate development and related programs + Supports the Labeling team in label development, review and approval activities,… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... needed for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing routine… more
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