- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides ... strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of… more
- Takeda Pharmaceuticals (Columbus, OH)
- …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
- Actalent (Prospect Heights, IL)
- Job Title: Regulatory Labeling Associate Job...Associate , you will work closely with the QA Director and the Regulatory Director ... Skills & Qualifications + Entry-level science graduates. + Interest in regulatory labeling . About Actalent Actalent is a global leader in engineering and… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs, Advertising and Promotion will be ... the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs, Advertising... impact of new campaign concepts, target, or product labeling , and to provide strategic regulatory guidance… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs** . The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she...support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for… more
- ADM (Kennesaw, GA)
- **92116BR** **Job Title:** Associate Director , Microbiome Regulatory Science - Kennesaw, GA **Department/Function:** Legal, Compliance, Regulatory ... Affairs, Corporate Security **Job Description:** ** Associate Director Microbiome - Decatur, IL; Chicago, IL: Erlanger, KY; Kennesaw, GA; or other ADM Location**… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** ** Associate Director , US Advertising & Promotion Regulatory Review** **Takeda Pharmaceutical** **Lexington, ... the role:** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review...for development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership… 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 (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New Product ... levels in one sensor. The role will also include responsibilities for regulatory support for on-market change management and manufacturing sites. The individual has… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to ... Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance....Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and cross-functional team… more
- AbbVie (Mettawa, IL)
- …with HEOR Strategy and other functions (eg, Clinical Development & Operations, Regulatory , Commercial). The Associate Director , Patient-Centered Outcomes ... key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / HTA meetings… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Medical Director , Clinical Science in our Gastrointestinal & Inflammation Therapeutic ... a vital contributor to our inspiring, bold mission **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for the overall global… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Medical Director Neurodegenerative Disorders in our Neuroscience Therapeutic Area Unit in ... a vital contributor to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for clinical studies… more
- Lilly (Durham, NC)
- …people who are determined to make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging is responsible for the staffing, ... and Packaging (DAP) production area at Lilly RTP. The Associate Director will help build a strong...and ensure compliance with area procedures and controls for labeling and packaging operations + Foster a strong quality… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position: Associate Director , WW Medical Neuropsychiatry Strategy, Schizophrenia** ... **Location: Princeton Pike or Madison, NJ** The Associate Director of Medical Strategy, Schizophrenia will partner with key medical team to support development,… more
- American Heart Association (Washington, DC)
- …career. The **American Heart Association** has a phenomenal opportunity for an ** Associate ** ** Regulatory Affairs Manager** with our Federal Advocacy Team in ... (hybrid work arrangements available. Under the direction of the Director , Federal Regulatory Affairs, you would be...of Agriculture (USDA). Core topics would include nutrition, food labeling , and prevention, with the opportunity to assist on… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- ThermoFisher Scientific (Greenville, NC)
- …trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor ... ( eg PBRER, PSUR, DSUR) as well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS, RMP and CSR). **General Support:** Ensures… more
- ThermoFisher Scientific (Wilmington, NC)
- …trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor ... ( eg PBRER, PSUR, DSUR) as well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS, RMP and CSR) **Essential Functions:** Manages… more
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