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Full-Time Head Of Regulatory jobs in Princeton, NJ

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SR. DIRECTOR, HEAD STATS PROGRAMMING HEMATOLOGY

Leads statistical programming activities across a Therapeutic Area and related oversight activities ensuring quality and timeliness. Leads the recruitment and retention strategies for Statistical Programming for CT Stats Programmi...

CompanyBiospace
AddressPrinceton, NJ
CategoryMedia & Communications
Job typeFull time
Date Posted 3 days ago See detail

Sr. Director, Head Stats Programming Hematology

Biospace

Princeton, NJ

Leads statistical programming activities across a Therapeutic Area and related oversight activities ensuring quality and timeliness. Leads the recruitment and retention strategies for Statistical Programming for CT Stats Programmi...

3 days ago seen See more...

Director, ICN Therapeutic Area Head, Phase IV Global Trial Management

Biospace

Princeton, NJ

Providing strategic and clinical operational leadership across a Therapeutic Area, for example: immunoscience/fibrosis; cardiovascular; solid tumors; cellular therapy or hematology. Assuring the implementation of that therapeutic...

4 days 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...

a week ago seen See more...

Summer 2024 - Regulatory Portfolio Management Internship

Bristol-Myers Squibb Company

Princeton, NJ

Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making, project availability d...

2 weeks ago seen See more...

Specialist - Regulatory Operations - Submissions

Biospace

Princeton, NJ

With direction from management participates on cross-functional teams focused on the planning and execution of regulatory submissions. This includes anticipating regulatory submission obstacles, identifying emerging issues and pro...

3 weeks 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...

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 days 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 days 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...

4 weeks ago seen See more...

Head of US Commercial Finance

Biospace

Princeton, NJ

Serve as a strategic partner to the US Commercial Organization, providing insights, reporting, and analytics to support key decisions and develop long-term business plans. This includes acting as a functional champion in Modernas...

a month ago seen See more...

Head of US Medical - Endocrine Medical Affairs

Ascendis Pharma

Princeton, NJ

$350,000 - $400,000 a year

Leads and directs the US Medical Directors to drive the development and execution of the US Medical Affairs strategy and tactics in alignment with key stakeholders. Develops and executes the US Medical Affairs Plans required for s...

a month ago seen See more...

Regulatory Lending Compliance Consultant

Wolf & Company Pc

Princeton, NJ

Coordinates and executes the regulatory compliance audit process. Develops and implements a risk based compliance audit plan, including scope determination, audit planning memos and reports. Plans, schedules and conducts each audi...

2 months ago seen See more...

SENIOR MANAGER REGULATORY AFFAIRS

Tk-Chain Llc

Princeton, NJ

$80,000 - $170,000 a year

Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Must be able to effective articulate c...

2 months 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...

Associate Director Regulatory Labeling

Acadia Pharmaceuticals Inc.

Princeton, NJ

Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management. Support implementat...

2 months ago seen See more...

Therapy Area Head - Cardio Renal-Medical Affairs

Biospace

Plainsboro, NJ

Deliver overall vision and strategy for the TA unit in consultation with TA leadership team. Responsible for setting the short-term and long-term (3-5 years) medical affairs priorities for the organization and ensure that these pr...

3 weeks 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...

a week ago seen See more...

Business Planning Head Adhesives Industrials and Electronics Americas

Henkel

Bridgewater, NJ

Defines and implements demand planning processes and strategy for the SBU in alignment with the overall SBU strategy. . Responsible for demand planning and forecasting KPIs. Analyzes business specific supply chain situations and d...

2 weeks 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...

4 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...

4 weeks ago seen See more...

Executive Director - North American Operations Supply Chain Head

Biospace

Plainsboro, NJ

Leading the NAO Commercial Supply Chain: Oversee the commercial Supply Chain for the US and Canada and lead the North American regional Supply Chain organization, ensuring operational efficiency, development, and alignment with gl...

2 months ago seen See more...

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...

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...

Head of B2B E-commerce

Sanofi

Bridgewater, NJ

Role OverviewAs the Head of B2B e-Commerce, you'll play a pivotal leadership role in shaping our ambitious roadmap and strategic direction for Sanofi's B2B e-commerce platform. Your expertise will span sales, marketing, technology...

3 weeks ago seen See more...

Medical Safety Head, PV (CHC)

Sanofi

Bridgewater, NJ

Management of Global Safety Leads (GSL), Signal & Risk Management Lead, PV Scientist(s) and administrative assistants. Ensure that the Medical Safety objectives are achieved, and compliance goals are met. Oversee safety strategies...

a month ago seen See more...

Head of Early Investment

Recordati Group

Bridgewater, NJ

$243K - $308K a year

Identify and evaluate potential Early Investment opportunities. Ensure appropriate diligence, valuation and senior management endorsement of the investment. Lead investment contract negotiation Ensure proper monitoring of the inve...

2 months ago seen See more...

Manager Regulatory Operations

Biospace

Bridgewater, NJ

Support regulatory submission activities associated with generating electronic submissions in support of IND/NDA applications. Responsible for the archival of submission and submission related documents in the EDMS. Contribute to...

2 months ago seen See more...

Supervising Research Scientist (Head of Cell Therapy Research Laboratory)

Rutgers University

New Brunswick, NJ

Approving the design and overseeing the coordination of immunology, T cell biology, and TCR discovery research projects within the laboratory, ensuring they align with research goals, strategies, and timelines. Planning, leading,...

2 months ago seen See more...

Head Soils and Plants Technician

Rutgers University

New Brunswick, NJ

Guides and instructs a group in diverse duties involving the layout and operation of land and experimental equipment pertaining to the research and development of Soils and Plants. Performs any duties of the group. Requires a high...

2 months ago seen See more...

Head Teacher: Infant and Toddler Room

Crossroads Early Learning Center

East Brunswick, NJ

Full time hours will primarily be 9 - 5 but may become earlier based on enrollment; Monday to Friday, year round. This position offers generous benefits and PTO after a 3 month introductory period, we are closed on major holidays....

2 months ago seen See more...

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What should I search to find Full-Time Head Of Regulatory jobs in Princeton, NJ?

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Top Jobs in Princeton, NJ

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What companies are hiring for Full-Time Head Of Regulatory jobs in New Jersey?

The top companies hiring now for Full-Time Head Of Regulatory jobs are Sun Pharmaceutical Industries,

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