Head Of Regulatory jobs in Mercer, 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 2 weeks 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...

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...

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...

Head of Supply Planning Network

Henkel

Bridgewater, NJ

$150,000 - $200,000 a year

Responsible for the strategic planning process for resulting in establishment of short- and long-term planning, profitability targets and contribution to company growth. Oversees the recruitment, employment, evaluation, and releas...

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...

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...

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...

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...

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...

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...

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...

Manager Global CMC Regulatory Affairs

Johnson & Johnson

Titusville, NJ

Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...

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...

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...

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...

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...

Preschool Teacher Assistant - Head Start Program

Children's Home Society

Trenton, NJ

Assist the Teacher in planning and implementing a comprehensive program including CHSofNJ HS curriculum, and Head Start Performance Standards. Work in a team setting with all staff to determine individual needs of the children. As...

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...

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...

Senior Director, Head Growth and Partnerships - Advanced Therapies Supply Chain

Johnson & Johnson

Raritan, NJ

Minimum of a Bachelors or equivalent University Degree required. Minimum 8 years of relevant work experience and/or business management. Experience within Pharmaceutical Cell Therapy, Biologics drug substance, or other similarly...

Global Head of HR, MedTech Digital

Johnson & Johnson

Raritan, NJ

Leverage internal and external insights to diagnose and design organizations optimized to achieve strategic goals. Design and deploy data-driven talent strategies that curate the talent and capabilities required to deliver. Shape...

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...

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...

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...

Executive Director, Global Clinical Operations Study Management Group Head

Biospace

Basking Ridge, NJ

With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medic...

Executive Director, Global Head of Regulated Clinical Bioanalysis

Biospace

Basking Ridge, NJ

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of pe...

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...

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...

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...