Full-Time Director Of Regulatory Affair jobs in New Brunswick, NJ

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DIRECTOR, GLOBAL REGULATORY AFFAIRS (GRL)

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...

CompanyBiospace
AddressBasking Ridge, NJ
CategoryInformation Technology
Job typeFull time
Date Posted 2 months ago See detail

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...

Medical Affairs-Scientific Director CV Renal

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...

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...

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...

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...

Global Senior Director Medical Affairs (GDMA) – Daiichi Alliance, Oncology

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...

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...

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...

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...

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...

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/...

Senior Manager CMC Regulatory Affairs

Biospace

Basking Ridge, NJ

Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...

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...

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...

Medical Affairs-Scientific Director CV Renal

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...

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...

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...

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...

Regulatory Affairs Associate - Drug Products (Princeton, NJ (USA), US)

Laboratoire Guerbet

Princeton, NJ

Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review. Coordinate preparation, review, submission of e-CTD regulatory dossiers t...

Senior Director, Global Medical Affairs Strategy - Solid Tumors

Genmab A/S

Princeton, NJ

Develop and execute the overall Medical Affairs Strategy for designated product in NSCLC therapeutic area. Serve on Compound Development Team as Global Medical Affairs representative; Co-Lead Global Commercialization Team. Serve a...

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...

Director of Regional Regulatory Vaccines Lead

Biospace

Summit, NJ

You will provide leadership to the respective Regional Team, overseeing all Regional Regulatory strategic and operational tasks for licensed products and development projects concerning the assigned therapeutic area.. Lead the est...