- Insmed Incorporated (San Diego, CA)
- …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from...and experience in the development and execution of Global regulatory strategyIn-depth knowledge and direct application of US… more
- Merck & Co. (North Wales, PA)
- …Owner for one or more of the QMS processes managed under GRACS(Global Regulatory Affairs & Clinical Safety) Quality &Compliance.Establishes and maintains an ... Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge.-Applies capabilities to enhance quality and builds capabilities of… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our ... regulatory submissions, maintaining licences and liaising with government authorities.The Regulatory Affairs Manager plays a critical part in ensuring… more
- Merck & Co. (Rahway, NJ)
- …we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality ... dedicated colleagues while developing and expanding your career.The Executive Director , Chemistry, Manufacturing & Controls ( CMC) , Pre-approval...projects as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays… more
- Eisai, Inc (Nutley, NJ)
- …that drives optimal access and utilization of Eisai marketed products in the United States .Provide input to the health economics and outcomes research ... your profile, we want to hear from you. The Director , US HEOR and RWE (field) is...the employment eligibility of all new hires in the United States . Please click on the following… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive workforcePlanning and Project Management In alignment with the Executive Director of US Medical Affairs , provides project management to ... Job DescriptionThe Regional Medical Scientific Senior Director - Team Lead (RMSD TL) is a credentialed therapeutic and disease expert (MD, PhD, PharmD, DNP, or DO)… more
- Merck & Co. (North Wales, PA)
- …Process, Metadata Management, Policy Implementation, Process Improvement Projects, Project Management, Regulatory Affairs Compliance, Regulatory Affairs ... Job DescriptionThe Associate Director of Data Operations Management plays a pivotal...responsible for ensuring data integrity, accessibility, and compliance with regulatory standards, while also enabling business users to derive… more
- Merck & Co. (North Wales, PA)
- …non-digital channels, and experience working with agenciesundefinedPreferred Skills:Understanding of US commercial and regulatory requirementsField sales and/or ... pipeline.We are currently recruiting for a results-driven and strategic Director , Product Marketing Owner - HCP for HIV. As...Strategy and Execution. This position will report to the US Commercial Leader (USCL), HIV Treatments and will be… more
- Merck & Co. (Durham, NC)
- … Regulatory Acumen and effective working relationship with Global Regulatory Affairs and Clinical Safety (GRACS) Demonstrated conflict resolution, ... Position Description: Under the direction of the Network Strategy & Execution Director , the Associate Director is responsible for assessing, leading and… more
- Merck & Co. (Montgomery County, PA)
- …in the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... and activities comply with local laws, industry codes, internal policies, and regulatory requirements.Our US marketing team has adopted an Agile Way… more
- Insmed Incorporated (San Diego, CA)
- …with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.ResponsibilitiesEDC System Design & ... 2025, we became Great Place to Work-certified in the US for the fifth year in a row. We...Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC programming,… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits,… more
- Merck & Co. (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Sumitomo Pharma (Tallahassee, FL)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US ....I-IV Research & Development Activities + As a Regional Regulatory Lead, manage regional ( United States… more
- Medtronic (Lafayette, CO)
- …to innovation in a more connected, compassionate world. **A Day in the Life** As the Director of Regulatory Affairs , you are a critical leader and the ... a high-performing and scalable organization. Mentor and coach senior regulatory affairs managers to enhance their skills...plan. The base salary range is applicable across the United States , excluding Puerto Rico and specific… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and..., Advertising and Promotion is responsible for providing commercial regulatory strategy to enable the US business… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research &… more
- Abbott (San Diego, CA)
- …Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic decision-making ... working mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs ** , works out of our… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek...cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities… more
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