Regulatory Affair Director jobs in Somerset, NJ
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GLOBAL SENIOR DIRECTOR MEDICAL AFFAIRS (GDMA) €“ DAIICHI ALLIANCE, ONCOLOGY
The Global Senior Director Medical Affairs (GDMA) is responsible for driving execution of scientific & Medical Affairs plans for their assigned Therapy Areas (TA) in key countries and regions. They are impactful members of Product...
| Company | Merck Sharp & Dohme |
|---|---|
| Address | Rahway, NJ |
| Category | Healthcare |
| Salary | $200,200 - $315,100 a year |
| Job type | Full-time |
| Date Posted | 8 hours ago See detail |
Global Senior Director Medical Affairs (GDMA) – Daiichi Alliance, Oncology New
Merck Sharp & Dohme
Rahway, NJ
$200,200 - $315,100 a year
The Global Senior Director Medical Affairs (GDMA) is responsible for driving execution of scientific & Medical Affairs plans for their assigned Therapy Areas (TA) in key countries and regions. They are impactful members of Product...
8 hours ago seen See more...
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Medical Affairs-Scientific Director CV Renal New
Biospace
Plainsboro, NJ
Identify and anticipate potential trends, changes to market conditions and areas of opportunity aligned with Therapeutic Area priorities. Utilizes subject matter expertise and analytical tools to provide deeper customer knowledge...
14 hours ago seen See more...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
4 weeks ago seen See more...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
4 weeks ago seen See more...
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Director, Regulatory Affairs Strategy, Hematology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
a month ago seen See more...
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Director, Global Regulatory Affairs (GRL)
Biospace
Basking Ridge, NJ
Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products. Seeks and incorporate regional and functional RA strategy into a global strate...
2 months ago seen See more...
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Director, Regulatory Affairs Companion Diagnostics
Biospace
Basking Ridge, NJ
CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing. At the time of implementation of a CDx study/...
2 months ago seen See more...
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Associate Director, Regulatory Affairs
Bausch + Lomb
Bridgewater, NJ
Provide Regulatory support and guidance in the development, revision, review, and approval of labeling artwork for Health Authorities submissions, as well as any post marketing labeling changes. Responsible for post approval lifec...
2 months ago seen See more...
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Associate Director, Regulatory Affairs
Johnson And Johnson
Somerville, NJ
Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist....
2 months ago seen See more...
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Associate Director, US Regulatory Affairs Strategy
Daiichi Sankyo, Inc.
Basking Ridge, NJ
Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...
2 months ago seen See more...
Associate Director - Regulatory Affairs - AD Promo
Biospace
Princeton, NJ
Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...
4 weeks ago seen See more...
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Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance
Ferring Pharmaceuticals
Parsippany, NJ
Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...
a month ago seen See more...
Associate Director / Director, Regulatory Affairs (Generic Medicines)
Cnam - Auditeurs - Accueil
Princeton, NJ
This role will work directly with the development and maintenance teams on the product registrations, through FDA communication and review process, amendments, supplements, and annual reports. Coordinates, reviews, and may prepare...
2 months ago seen See more...
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VP/TA Head, General Medicine - Global Regulatory Affairs
Merck
Rahway, NJ
Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.. Contributing to the continuous improvement of the operating model for regulatory a...
3 days ago seen See more...
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Senior Director, Head of Global Medical Affairs for Pulmonary Hypertension
Johnson & Johnson
Raritan, NJ
Provide medical leadership in interactions with external stakeholders (HA bodies, external experts, advisory boards). Execution: Provide leadership, scientific input and guide the development of key Medical Affairs deliverables...
3 days ago seen See more...
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Manager - Regulatory Affairs - Therapeutic Area
Biospace
Plainsboro, NJ
Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...
a week ago seen See more...
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Associate Director, Scientific Sales Affairs
Merck
Rahway, NJ
Hire, onboard, lead, coach, and motivate field veterinary staff of the Companion Animal Business Unit to build strong customer relationships and advance our company's offerings through medical education and needs discovery.. Provi...
5 days ago seen See more...
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USA Regulatory Affairs Specialist Project Lead I Scientific
Adecco
Bridgewater, NJ
$ 88 - $ 89.22 / Hour
Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...
3 weeks ago seen See more...
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Director - Global Regulatory Lead
Biospace
Plainsboro, NJ
Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulato...
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Senior Associate - Regulatory Affairs
Biospace
Princeton, NJ
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...
2 weeks ago seen See more...
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Director, Regulatory Labeling
Biospace
Bridgewater, NJ
CCDS. regional prescribing information (e.g., USPI, SmPC, Japan PI). medication guides. patient information/leaflet/instructions for use. package labels. coordinating with multidiscipline team for US commercial implementation...
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Regulatory Affairs Consultant
Katalyst Healthcares And Life Sciences
Rahway, NJ
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...
3 weeks ago seen See more...
Regulatory Affairs Consultant
Katalyst Healthcares & Life Sciences
Rahway, NJ
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...
3 weeks ago seen See more...
US Associate Director Payer & Access Strategy, Medical Affairs, Oncology (Remote)
Merck
Rahway, NJ
The US Associate Director Payer & Access Strategy Lead, Medical Affairs (US AD PASL) role supports the Global Medical and Scientific Affairs (GMSA) strategic priority "Invest in the growth, success and well-being of our people" an...
3 weeks ago seen See more...
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Associate Manager, Regulatory Affairs
Kenvue
Skillman, NJ
Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...
2 months ago seen See more...
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Associate Manager, Regulatory Affairs
Johnson & Johnson Consumer Inc.
Skillman, NJ
Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...
2 months ago seen See more...
Specialist - Regulatory Affairs
Biospace
Plainsboro, NJ
Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...
a month ago seen See more...
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Manager - Regulatory Affairs - Therapeutic Area
Biospace
Plainsboro, NJ
Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...
a month ago seen See more...
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Senior Director, Global Regulatory Intelligence & Policy
Biospace
Basking Ridge, NJ
Leads day-to-day a team of Regulatory Intelligence Policy professionals across all major regions, incl. mentorship, performance mgmt., etc. Supports the team in both Regulatory Intelligence (collection, interpretation and communic...
4 weeks ago seen See more...
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Medical Director, Bladder - Global Medical Affairs Oncology
Johnson & Johnson
Raritan, NJ
This position requires a minimum of an advanced degree in medicine (i.e. M.D. or equivalent). A trained Oncologist, or an individual with substantial previous experience in conducting oncology clinical studies is highly desired....
4 weeks ago seen See more...
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