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Full-Time Director Of Regulatory Affair jobs in New Jersey

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DIRECTOR, REGULATORY AFFAIRS STRATEGY - GENETIC MEDICINE

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...

CompanyBiospace
AddressBasking Ridge, NJ
CategoryInformation Technology
Job typeFull time
Date Posted a month ago See detail

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...

a month ago seen See more...

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...

a month 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...

a month ago seen See more...

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...

Director, Regulatory Affairs - Pharmaceuticals

Stryker

Mahwah, NJ

Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level. Creates long term regulatory strategy for drug products, provides input on combina...

2 months ago seen See more...

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...

2 months ago seen See more...

Senior Manager, Regulatory Affairs - General Medicine

Biospace

Basking Ridge, NJ

Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...

3 days ago seen See more...

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...

7 days ago seen See more...

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...

2 weeks ago seen See more...

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...

2 weeks ago seen See more...

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...

3 weeks ago seen See more...

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...

3 weeks ago seen See more...

Director, Regulatory CMC

Biospace

Jersey City, NJ

Develop and implement regulatory strategies for CMC aspects of our pharmaceutical products, including preparing and submitting regulatory submissions to regulatory agencies. Interact with regulatory agencies to ensure compliance w...

4 weeks ago seen See more...

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...

4 weeks ago seen See more...

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...

a month 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...

a month 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...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

4 weeks ago seen See more...

Scientific Director, Medical Affairs- CNS/Psychiatry

Biospace

Florham Park, NJ

Develops and initiates Medical Affairs activities, generation and dissemination of data supporting the overall scientific strategy. Lead or provide input into the design, analysis, interpretation, and reporting of scientific and m...

a month ago seen See more...

Medical Director, Medical Affairs- CNS/Psychiatry

Biospace

Florham Park, NJ

Initiate and lead Medical Affairs activities, data generation and dissemination supporting the overall medical/scientific strategy.. Lead or supportthe design, analysis, interpretation, and reporting of scientific content of study...

a month ago seen See more...

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...

a month ago seen See more...

Associate Director, Graduate Affairs Communications Specialist & CRM Administrator

Seton Hall University

Orange, NJ

The incumbent will assist with the general coordination of all graduate enrollment and recruitment efforts by providing critical strategic leadership where technology, data, reporting, and digital communications are concerned. M...

2 months ago seen See more...

Associate Director of Athletics for Internal Affairs

Kean University

Union, NJ

Please upload your resume/CV for automatic population of information to your Kean application. Your contact information, work experience and education will be automatically filled in. Please review all fields you will need to ve...

a month ago seen See more...

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...

a month ago seen See more...

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...

a month ago seen See more...

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The top companies hiring now for Full-Time Director Of Regulatory Affair jobs are Insight Recruitment LLC, Insight Recruitment, LLC,

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