- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , DRA Product Labeling will lead and manage ... labeling initiatives in compliance with Corporate and local regulatory requirements. The AD, DRA Product Labeling ... labeling section of NDA Annual Reports. **Requirements** Associate Director : + Bachelor's degree with a… 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
- Gilead Sciences, Inc. (Santa Monica, CA)
- …together we can continue making a positive impact in the cancer field. The Associate Director , Regulatory Affairs, Advertising and Promotion is responsible ... to US marketing activities focused in cell therapy. The Associate Director will report to a Senior...regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic… 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 providing strategic regulatory guidance on… 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
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... + Update the internal tracker that records all incoming and outgoing regulatory activities/communications for ANDAs/OTCs which may include submissions to FDA and… more
- Sanofi Group (Cambridge, MA)
- **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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs, you will act as ... regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** 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 + Responsible for creating and reviewing SOPs and… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... on mission, prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy + Ensures… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory data models, RIM systems (Veeva Vault preferred)** , and Regulatory processes ( Labeling , CMC, Registrations). + Excellent analytical and ... the best of my knowledge. **Job Description** **Summary:** The Regulatory Data Governance Lead will ensure Regulatory ...The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with Takeda's… more
- Ascendis Pharma (Princeton, NJ)
- …As a member of the Endocrine Medical Sciences team for the US business, the Associate Medical Director supports the US Medical Director for deliverables and ... boundaries of company compliance SOP's and US regulations). The Associate Medical Director is expected to develop...for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling ,… more
- AbbVie (Waltham, MA)
- …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
- OneMain Financial (Baltimore, MD)
- The Associate Director - Data Security Technologies will join our growing cybersecurity team and is ideally based Baltimore, MD. Candidates may also be ... considered in Fort Worth, Evansville, and Fort Mill. The Associate Director - Data Security Technologies will...Data Loss Protection, Prevention (DLP), data inventory, and data classification/ labeling , and will play a key role in safeguarding… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or co-lead of… more
- Organon & Co. (Jersey City, NJ)
- …INDs, briefing books and other regulatory documents, as applicable. The Associate Director , Biopharmaceutics will be the primary author for module 2.7.1 ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert...responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …will inspire you and empower you to shine? Join us as an Associate Medical Director , Clinical Science, Neuroscience- Pulmonologist/Neurologist in our Cambridge, ... be a vital contributor to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for the overall global… more
- Lundbeck (Deerfield, IL)
- Associate Director Medical Affairs - Neurology Requisition ID: 7013 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... - open to candidates anywhere in the greater United States** **SUMMARY:** The Associate Director , Medical Affairs, Neurology serves as the internal scientific… more
- ThermoFisher Scientific (Wilmington, NC)
- …work in the United States without sponsorship. **Discover Impactful Work:** The Associate /Medical Director provides medical oversight of clinical trials to ... case-processing activities through all phases of development and perform regulatory reporting and medical monitoring. As part of your...meet the requirements of the role. Job leveling at Associate Medical Director or Medical Director… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , US Medical Neuropsychiatry position works in the US ... manage integration points across US functional and commercialization areas to ensure alignment. The Associate Director will report to the Senior Director , US… more