- 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
- 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
- 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
- Novo Nordisk (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… 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
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global… 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
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. Associate Director , Medical Safety Science reports to Head of Global Medical Safety ... all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management.… more
- Abbott (Alameda, CA)
- …way patients and professionals measure, track and analyze glucose levels. As an Associate Director , project leadership, you will be responsible for Managing one ... budget and on strategy. These activities include coordination of artwork and labeling , in-house and third-party manufacturing, inventory phase in and phase out,… more
- ThermoFisher Scientific (Carlsbad, CA)
- …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
- Merck (Rahway, NJ)
- …clinical trials. Global Clinical Supply is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. ... Global Clinical Supply Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,… more
- Oatey (Cleveland, OH)
- …in continuous improvement opportunities and related project assignments. + Provide regulatory verification of information on printed labeling , catalogs and ... Director , Product Compliance _Share by Email_ _Share on...contact/coordinator for all interactions with standards bodies, associations, and regulatory groups relevant to the Company's business. Participates where… more
- Compass Group, North America (New York, NY)
- …but the start of a career where you can flourish. Job Summary The Director of Quality Assurance will lead the development and execution of comprehensive QA programs ... standards. This position is responsible for ensuring that all food safety, regulatory , and quality requirements are met, while maintaining the distinctive Kirkland &… more
- Actalent (Buena Park, CA)
- …effective collaboration. The team currently includes the VP of Director , Formulations & Regulatory Affairs, and one associate , and will expand with a new ... pharma. + Detail-oriented with experience in FDA regulations and regulatory documents. + Knowledge of labeling requirements....Director of Regulatory starting mid-December. The company uses both national and… more
- AbbVie (North Chicago, IL)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. ... of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. + Responsible,… more
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