Associate Director of Regulatory Labeling Strategy

**SUMMARY OF POSITION** The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions will include ANDAs, amendments, supplements, Annual Reports and advertising...

Job DescriptionJob DescriptionThe Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. The RA Associate Director, Labeling will be overall responsible for ensuring...

Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

Job DescriptionJob DescriptionPMV Pharmaceuticals Inc.Job Description: Executive Director, Head of Regulatory AffairsReports to: Chief Development OfficerLocation: Hybrid (2 days a week in Princeton, NJ office)Position OverviewThe Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the...

PMV Pharmaceuticals Inc. Job Description: Executive Director, Head of Regulatory Affairs Reports to: Chief Development Officer Location: Hybrid (2 days a week in Princeton, NJ office)Position Overview The Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the company meets its objectives....

Certara USA, LLC Associate Director, US Access Strategy Princeton , New Jersey Apply Now The Associate Director (AD), US Access Strategy is a senior consultant role within Certara's US Evidence and Access team. The AD will have autonomous leadership of project teams and client accounts. Associate Directors lead the delivery of multiple simultaneous client...

SUMMARY OF POSITION ORGANIZATION STRUCTURE The Director, Regulatory Affairs reports into the VP, Regulatory Affairs and is based in Pine Brook, New Jersey. Manages team of 2-5 direct and indirect reports. RESPONSIBILITIES QUALIFICATIONS - Advanced degree in a life science.Minimum of 12 years of pharmaceutical industry experience, at least 10 of those...

We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will: Develop and execute novel drug regulatory strategy Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines Establish sound regulatory advice/position on key development issues,...

Associate Director, Strategy & Media Relations page is loaded Associate Director, Strategy & Media Relations Apply locations Princeton - NJ - US time type Full time posted on Posted 3 Days Ago job requisition id R1581749 Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol...

**SUMMARY OF POSITION** Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates,...

Job DescriptionJob DescriptionOur Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and...

About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and...

Guerbet is a human-scale company that aims to become a new global leader in medical imaging. Pioneer in contrast media with 90 years' experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors. The company offers a comprehensive range of...

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! * Hybrid work arrangement* Medical, Dental, Vision Benefits* Health Savings Account (HSA), Flexible Spending Account (FSA)* Prescription Drug Coverage* Telehealth and Behavior Health Services* Income Protection - Short Term and Long Term Disability Benefits* Retirement Benefits - 401k Company...

Apply now " Date: Apr 30, 2024 Location: Princeton, NJ (USA), US Job Type: Graduate At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and...

Apply now " Date: Apr 30, 2024 Location: Princeton, NJ (USA), US Job Type: Graduate At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional...

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

Job DescriptionJob DescriptionDevelop global regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. Responsibilities: Develop global or US regulatory strategy for Oncology products in development and through life cycle management,...

About the Department Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future...