Regulatory Affairs Intern

2 weeks ago

West Islip, New York, United States Cipla Full time
Job Title

Spring 2025 Regulatory Affairs Intern

Company Overview

Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies.

Job Summary

We are seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. The successful candidate will be responsible for developing product labeling, including package inserts, container labels, and Medication Guides, for pending and approved ANDAs. Additionally, they will be responsible for archival of electronic submission documents and writing, critical reviewing, compiling, and publishing FDA submissions in eCTD format.

Key Responsibilities
  • Develop product labeling, including package inserts, container labels, and Medication Guides, for pending and approved ANDAs
  • Archival of electronic submission documents
  • Writing, critical reviewing, compiling, and publishing FDA submissions in eCTD format
  • Reviewing CMC data for adequacy and conformance to regulatory requirements and acceptability of documents for submissions
  • Communicating effectively with internal departments, external vendors, and partners to achieve project goals and submission timelines
Requirements
  • BS degree in Pharmacy, Regulatory Affairs, or related field
  • 0-1 year of experience in regulatory affairs or related field
  • Proficiency in applicable computer and database applications, including MS Word, MS Excel, PowerPoint, and PDF
  • Ability to manage timelines, be well-organized, detail-oriented, and have the ability to multi-task and manage changing priorities
  • Demonstrable knowledge of FDA regulations and FDA/ICH guidelines
About Cipla

Cipla is a fast-growing pharmaceutical company with a continued focus on expanding our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals, Inc. is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with a focus on a range of therapeutic areas.

Equal Opportunity Employer

Cipla is an equal opportunity employer and welcomes people of all abilities. We want to ensure that our hiring and interview process meets the needs of all applicants.

  • Regulatory Affairs Specialist

    3 weeks ago

    West Islip, New York, United States Cipla Full time

    Job TitleSpring 2025 Regulatory Affairs InternCompany OverviewCipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies.Job SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. The...

  • Quality Assurance Compliance Specialist

    4 weeks ago

    West Islip, New York, United States Cipla Full time

    About the RoleCipla is seeking a highly motivated and detail-oriented Quality Assurance Compliance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.ResponsibilitiesPerform basic archiving tasks with Doc control using current...

  • Quality Assurance Compliance Specialist

    4 weeks ago

    West Islip, New York, United States Cipla Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Compliance Intern to join our team at Cipla. As a Quality Assurance Compliance Intern, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesPerform basic archiving tasks with Doc control using current...

  • Quality Assurance Compliance Specialist

    4 weeks ago

    West Islip, New York, United States Cipla Full time

    About the RoleCipla is seeking a highly motivated and detail-oriented Quality Assurance Compliance Intern to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.ResponsibilitiesPerform basic archiving tasks with Doc control using current...

  • Quality Assurance Compliance Specialist

    4 weeks ago

    Central Islip, New York, United States Invagen Pharmaceuticals Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Compliance Specialist to join our team at InvaGen Pharmaceuticals. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.ResponsibilitiesPerform basic archiving tasks with Doc...

  • Senior Quality Assurance Manager

    5 days ago

    West Islip, New York, United States Invagen Pharmaceuticals Full time

    About Invagen PharmaceuticalsInvagen Pharmaceuticals is a leading global pharmaceutical company dedicated to delivering high-quality, innovative medicines to patients worldwide. With a strong presence in the US market, we are committed to making a positive impact on people's lives.Job Title: Senior QA ManagerWe are seeking an experienced Senior QA Manager to...

  • Senior Commercial Lines Underwriter

    3 days ago

    West Islip, New York, United States KING'S INSURANCE STAFFING LLC Full time

    Job Title: Sr. Commercial Lines UnderwriterWe are seeking a highly skilled and experienced Sr. Commercial Lines Underwriter to join our team at KING'S INSURANCE STAFFING LLC.About the Role:This is a unique opportunity to work with a leading National Insurance Carrier, responsible for underwriting and managing a portfolio of both admitted and non-admitted...

  • Pharmacy Graduate Intern

    3 weeks ago

    West Orange, New Jersey, United States Walgreens Full time

    Job SummaryWalgreens is seeking a highly motivated and detail-oriented Pharmacy Graduate Intern to join our team. As a Pharmacy Graduate Intern, you will have the opportunity to gain hands-on experience in a fast-paced retail pharmacy environment while working under the direct supervision of a licensed pharmacist.Key ResponsibilitiesProvide pharmacy...

  • Quality Assurance Director

    10 hours ago

    Central Islip, New York, United States NESCO Inc Full time

    Job Summary:Nesco Inc is seeking a highly experienced Quality Assurance Director to lead our quality management system and ensure compliance with regulatory requirements.Responsibilities:Develop and maintain a Quality Management System (QMS) in accordance with 21 CFR Part 11 requirements.Ensure product quality and compliance of all manufactured and released...

  • Associate Director of Congregate Care

    2 weeks ago

    Islip Terrace, New York, United States Mercy Haven Full time

    Job Title: Associate Director of Congregate CareAt Mercy Haven, we are seeking a highly skilled and experienced Associate Director of Congregate Care to join our team. As a key member of our leadership team, you will be responsible for overseeing the congregate care programs, ensuring compliance with regulatory requirements, and fostering a culture of...

  • Senior Quality Assurance Manager

    4 days ago

    Central Islip, New York, United States Cipla Full time

    About CiplaCipla is a leading global pharmaceutical company dedicated to delivering high-quality, branded, and generic medicines. With a strong presence in India, South Africa, the U.S., and other emerging markets, we are trusted by healthcare professionals and patients worldwide. Our commitment to 'Caring for Life' drives our focus on making affordable,...

  • Real Estate Acquisition Specialist

    3 weeks ago

    Central Islip, New York, United States Helpful House Buyers Full time

    Job OverviewWe are seeking a highly skilled Real Estate Acquisitions Manager to join our team at The Helpful House Buyers. As a key member of our acquisitions team, you will be responsible for identifying and acquiring potential real estate investment opportunities that align with our company's goals and objectives.Key ResponsibilitiesIdentify and evaluate...

  • Manufacturing Process Developer

    4 weeks ago

    Central Islip, New York, United States Invagen Pharmaceuticals Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Manufacturing Intern to join our team at InvaGen Pharmaceuticals. As a key member of our manufacturing team, you will be responsible for assisting in the development and optimization of manufacturing processes, participating in the execution of batch records, and conducting analytical...

  • Pharmacy Professional

    2 weeks ago

    West Hempstead, New York, United States CVS Health Full time

    Join CVS Health as a Pharmacy InternWe are seeking a motivated and detail-oriented Pharmacy Intern to join our team at CVS Health. As a Pharmacy Intern, you will play a critical role in ensuring a safe and effective Retail Pharmacy work environment that delivers exceptional care to each patient.Key Responsibilities:Assist licensed pharmacists in providing...

  • Pharmacy Professional

    4 days ago

    West Hempstead, New York, United States CVS Health Full time

    Job SummaryWe are seeking a motivated and detail-oriented Pharmacy Intern to join our team at CVS Health. As a Pharmacy Intern, you will play a critical role in ensuring a safe and effective Retail Pharmacy work environment that delivers exceptional care to each patient.Key ResponsibilitiesAssist licensed pharmacists in providing patient care and ensuring...

  • Quality Assurance Specialist

    3 days ago

    West Nyack, New York, United States LJ Gonzer Associates Full time

    We are seeking a highly skilled Quality Assurance Auditor to join our team at L.J Gonzer Associates. As a Quality Assurance Auditor, you will be responsible for ensuring the quality and regulatory compliance of our client's cosmetics manufacturing processes.Your key responsibilities will include:Managing user databases and maintaining quality systems and...

  • RF Systems Performance Engineer

    3 days ago

    West Nyack, New York, United States The Judge Group Full time

    RF Systems Performance EngineerAs an RF Systems Performance Engineer, you will play a key role in designing and optimizing our network to ensure crystal-clear connections and top-notch call performance. Your expertise in RF theory and practice, as well as 5G and LTE/VoLTE technology, will be instrumental in making our network the best it can be.Key...

  • Quality Assurance Specialist

    4 days ago

    West Nyack, New York, United States gonzer Full time

    Quality Assurance CoordinatorWe are seeking a highly skilled Quality Assurance Coordinator to join our team at L.J Gonzer Associates. This role will be responsible for ensuring Enterprise-wide Quality and Regulatory compliance and continuous improvement through the implementation and maintenance of robust quality systems and processes.Key...

  • RF Systems Performance Engineer

    4 weeks ago

    West Nyack, New York, United States The Judge Group Full time

    RF Engineer Net Systems PerformanceWe are seeking a skilled RF Engineer to join our network engineering team. As an RF Engineer, you will play a key role in redesigning mature network areas to minimize capacity constraints and improve SINR. You will work closely with other areas of the network to ensure performance fixes and initiatives are in place.Key...

  • RF Systems Performance Engineer

    1 month ago

    West Nyack, New York, United States The Judge Group Full time

    RF Engineer Net Systems PerformanceWe are seeking a skilled RF Engineer to join our team in West Nyack, NY. As an RF Engineer, you will play a key role in designing and optimizing our network to ensure top-notch call performance and crystal-clear connections for our customers.Key Responsibilities:Redesign mature network areas to minimize capacity constraints...