Current jobs related to Lead Regulatory Affairs Consultant - Princeton, New Jersey - Intellectt Inc

  • Regulatory Affairs Strategy Lead

    3 days ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States Genmab AS Full time

    Job Title: Regulatory Affairs DirectorGenmab is seeking an experienced Regulatory Affairs Director to join our Global Regulatory Affairs organization. As a key member of our team, you will be responsible for developing and implementing global and US regulatory strategies to advance our portfolio of development pipeline candidate drugs.Key...

  • Senior Director, Regulatory Affairs Strategy Lead

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs Strategy **Job Summary** We are seeking a highly experienced Senior Director, Global Regulatory Affairs Strategy to provide regulatory affairs strategic leadership for our company and novel drug development programs. **Key Responsibilities:** * Develop and execute novel drug regulatory strategy * Ensure...

  • Senior Director, Regulatory Affairs Strategy Lead

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title:Senior Director, Regulatory Affairs StrategyJob Summary:We are seeking a highly experienced Senior Director, Regulatory Affairs Strategy to provide strategic leadership for our company's regulatory affairs and novel drug development programs. The successful candidate will be responsible for developing and executing the overall regulatory strategy,...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job Title: Director, Global Regulatory LeadThe Director, Global Regulatory Lead is a key member of the regulatory team, responsible for ensuring compliance with regulatory requirements and guidelines. This role requires a strong understanding of regulatory affairs and the ability to communicate effectively with cross-functional teams.Key...

  • Senior Director, Regulatory Affairs Strategy Lead

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Regulatory Affairs Strategy LeadThe position will provide strategic leadership for the company's regulatory affairs and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and...

  • Senior Director, Regulatory Affairs Strategy Lead

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Strategic Regulatory Affairs LeadershipThe Senior Director, Regulatory Affairs Strategy will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. This position will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway,...

  • Regulatory Affairs Manager

    1 week ago

    Princeton, New Jersey, United States TK-CHAIN LLC Full time

    Job Title: Regulatory Affairs ManagerJob Summary: We are seeking a highly skilled Regulatory Affairs Manager to join our team at TK-CHAIN LLC. The successful candidate will be responsible for managing regulatory activities associated with planning, authoring, compiling, and submitting high-quality regulatory submissions to the FDA within company timelines...

  • Senior Manager Regulatory Affairs

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Our Team as a Senior Manager, Regulatory AffairsSun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company, and we are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of...

  • Regulatory Affairs Director

    2 weeks ago

    Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Job OverviewLynkx Staffing LLC is seeking a highly experienced Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to lead global teams in developing and executing regulatory strategies for pharmaceutical clients.Develop and implement regulatory strategies for CMC components of drug development programs, collaborating with project teams and...

  • Regulatory Affairs Senior Manager

    4 days ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Unlock Your Potential in Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of regulatory documents to health authorities worldwide.Key...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job Title: Director, Global Regulatory LeadThe Director, Global Regulatory Lead is responsible for providing strategic direction and guidance for product development and regulatory submissions. This role requires a strong understanding of regulatory requirements and the ability to communicate effectively with cross-functional teams.Key...

  • Global Director Regulatory Affairs Strategy

    1 week ago

    Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Job Title: Global Director Regulatory Affairs StrategyJob Description:At Lynkx Staffing LLC, we are seeking a highly skilled Global Director Regulatory Affairs Strategy to lead our global teams in the development and execution of regulatory strategy.Key Responsibilities:* Lead Regulatory Affairs Functional Teams (RAFTs) to ensure high-quality strategic...

  • Regulatory Affairs Director

    1 week ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job SummaryThe Director, Regulatory Strategy is responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.Key ResponsibilitiesDevelop and execute regulatory strategies...

  • Regulatory Affairs Strategy Director

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide strategic leadership for the company's regulatory affairs and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and...

  • Regulatory Affairs Specialist

    4 days ago

    Princeton, New Jersey, United States Avance Consulting Full time

    Job Title: Regulatory Affairs ManagerJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to support our client in the preparation and submission of Clinical Trial Applications (CTAs) within the EU Clinical Trial Regulation (CTR) framework.Key Responsibilities:* Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS)...

  • Director of Regulatory Affairs Strategy

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide strategic leadership for the company's regulatory affairs and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and...

  • Regulatory Affairs Director

    2 weeks ago

    Princeton, New Jersey, United States TK-CHAIN LLC Full time

    Job SummaryThe Director of Regulatory Affairs will play a key role in ensuring the compliance of our clients' drug development programs with US regulatory guidelines and federal regulations. This individual will be responsible for integrating and applying knowledge of regulatory guidelines and federal regulations to all aspects of our clients' drug...

  • Regulatory Affairs Strategy Director

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs.Key ResponsibilitiesDevelop and execute novel drug regulatory strategyEnsure development programs are compliant with ICH regulatory requirements and all local country...

  • Global Director Regulatory Affairs Strategy

    3 weeks ago

    Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Job OverviewLynkx Staffing LLC is seeking a highly skilled Global Director Regulatory Affairs Strategy to lead our client's global teams in the development and execution of regulatory strategy.Key ResponsibilitiesLead Regulatory Affairs Functional Teams (RAFTs) to ensure high-quality strategic regulatory input is provided to optimize regulatory outcomes and...

Lead Regulatory Affairs Consultant

2 months ago

Princeton, New Jersey, United States Intellectt Inc Full time

Position: Senior Regulatory Affairs Specialist

Company: Intellectt Inc

Role Overview:

This role involves collaborating with various departments to enhance and refine regulatory affairs processes. The specialist will support the execution of strategies and operations related to regulatory affairs, which includes overseeing the preparation of product registration submissions, progress reports, amendments, and periodic experience reports.

Key Responsibilities:

  • Develop and revise procedures for regulatory affairs to adapt to changes in the regulatory environment, particularly concerning EU MDR.
  • Identify opportunities for process improvements within regulatory affairs and ensure successful implementation.
  • Assist in the preparation and submission of regulatory documents in compliance with US and EU medical device regulations.
  • Support both internal and external inspections, ensuring adherence to regulatory standards.
  • Work collaboratively across functions in a matrixed organization to achieve regulatory objectives.
  • Engage in continuous improvement initiatives to enhance regulatory processes.

Required Qualifications:

  • 3-5 years of experience in Medical Device Regulatory Affairs.
  • Proficient understanding of EU MDR and Regulatory Change Assessment.
  • Experience with US 510K submissions within the last five years.
  • Demonstrated ability in technical writing and communication skills.
  • Experience with IVD devices in a regulatory context.
  • Ability to provide technical writing samples as part of the application process.

Educational Background: A Bachelor's Degree is required.