- Eisai, Inc (Nutley, NJ)
- …also consider remote based.Eisai Salary Transparency Language:The annual base salary range for the Director , Global Regulatory Affairs , Growth Markets is ... your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets...broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there's only one choice. Director Global Regulatory Strategy (Molecular Imaging, Pharmaceuticals) The position ... TASKS AND RESPONSIBILITIES The primary responsibilities of this role, Director Global Regulatory Strategy (Molecular... project goals from development through life cycle; Represents Global Regulatory Affairs on assigned… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely. Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement ... and influencing the field as applicable. Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. The opportunity The Associate Director , Global Regulatory Affairs , will be responsible for ... Associate Director , Regulatory Affairs Date:...respiratory, dermatology, gastroenterology, or other therapeutic areas within the Global Regulatory Affairs Innovative Medicines… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing ... global regulatory strategies and plans to enable...PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in … more
- Boehringer Ingelheim (Athens, GA)
- …team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs ( RA ) core or subteam member in projects as ... Description Manager The Manager, Regulatory Affairs ( RA ) Pharma...) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global … more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs , Tactical Implementation, you'll have a ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the ...critical role in hands-on execution and oversight of global regulatory submission activities across assigned programs… more
- GRAIL (Boise, ID)
- …products with the FDA and/or global health authorities. Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. Perform other duties as assigned. Required… more
- BeOne Medicines (San Mateo, CA)
- General Description: The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders....candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Director Commercial Regulatory Affairs Description : The role of ... Associate Director of US Commercial Regulatory Affairs requires the ability to apply...Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday,… more
- Organon & Co. (Plymouth Meeting, PA)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Job Description **The Position ** Reporting to the Director in Organon Regulatory CMC, the...established business processes and systems. Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Eisai, Inc (Bethesda, OH)
- …budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate ... strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and business development programs. Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... environment. Job Description Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated… more
- Otsuka America Pharmaceutical Inc. (Richmond, VA)
- …Actions (CAPA), Deviations, and Change Control , ensuring compliance with global regulatory requirements and internal standards. The successful candidate ... Job Summary The Associate Director , Global Product Quality - GMP...ensure alignment with corporate quality objectives Cross-functional Leadership:Collaborate with Regulatory Affairs , Technical Operations, Manufacturing, and Supply… more
- Takeda Pharmaceuticals (Boston, MA)
- …with key functions across Takeda Oncology including Translational Medicine, Clinical Sciences, Global Regulatory Affairs , the Oncology Business Unit ... and empower you to shine? Join us as a Director , Global Program Management in our Cambridge...clinical data integration. Understanding of key considerations relevant to global regulatory requirements Experience developing team culture,… more
- Insmed Incorporated (NJ)
- …Are:You have a Bachelor's degree along with 5+ years of experience in Medical Affairs , Regulatory Affairs , or related functions within the pharmaceutical or ... (MRC) Operations is responsible for managing the operational execution of the company's Global We're looking for an Associate Director , Medical Review Committee… more
- Merck & Co. (Rahway, NJ)
- …marketing teams within the organization along with sales, product development, regulatory affairs , customer service, and other cross-functional teams to ... and ability to successfully partner cross functionally with all business units, regulatory , legal, and with Global Marketing colleagues Demonstration of computer… more
- Insmed Incorporated (NJ)
- …team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality, and ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand… more
