- Merck & Co. (Rahway, NJ)
- …possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information ... Job DescriptionAssociate Director , Business System Labeling Management Required...Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling , … more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The Global Regulatory Labeling , Policy and Intelligence Associate Director will primarily be responsible for ... be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling , Policy and Intelligence. The position may be based in our Princeton,… 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
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is responsible… more
- Merck (Rahway, NJ)
- **Job Description** ** Associate Director , Business System Labeling Management** **Required experience and skills:** + Min. 5-10 years of experience with ... a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory ...Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling , … 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)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... 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
- Chiesi (Cary, NC)
- …new labeling and changes to existing labeling , and submission of labeling information to regulatory authorities in the United States and Canada. Main ... duties in Canada. + Manage and oversee the submission of promotional labeling materials and supporting documentation to regulatory agencies in accordance… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development ... and guidance and correctly apply them as appropriate in product development and labeling regulatory + Regulatory Affairs Certification by RAPS a plus The… 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 ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION ... : Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance...of data related to the drug development lifecycle, including regulatory submissions, labeling , and product tracking; Oversee… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...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 ... RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory ...GMPs) + Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …become your best self. Become a **maker of possible** with us. **Job Overview** The Associate Director of Regulatory Affairs will provide regulatory ... activities, developing and maintaining documentation for compliance programs such as labeling , promotional material review, and other regulatory requirements.… 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
- Edwards Lifesciences (Irvine, CA)
- …we are supporting the needs and interests of the patients we serve. The Senior Director , Corporate & Regulatory Counsel role is a blend of subject matter legal ... expert and strong business acumen. The Senior Director , Corporate & Regulatory Counsel will have...in Irvine CA and reporting to Senior Vice President, Associate General Counsel, TAVR General Counsel. The successful candidate… more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for ... and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory...Review Team (PLRT) and in collaboration with US RA Labeling Content, provide regulatory support during Annual,… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... in departmental activities **Supervisory Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a team that… more
