Intern – Regulatory Affairs

Job TitleSpring 2025 Regulatory Affairs InternOrganization NameInvaGen Pharmaceuticals, Inc.LocationCentral Islip, NY locationEmployment TypeFull TimeSalary Range(Base/salary)Based on education 19 to 27/hrBenefitsPaid holidays that fall within the sessionWork Hours/ Shift/ Remote8:30 am – 5pm Mon- FriResponsibilities/ Accountabilities

• Responsible for development of product labeling, including package inserts, container labels, Medication Guides, for the pending and approved ANDAs
• Responsible for archival of the electronic submission documents in the product specific files.
• Write, critical review, compile, and publish FDA submissions as needed in eCTD format.
• Responsible for reviewing CMC data for adequacy and conformance to regulatory requirements and acceptability of documents for submissions.
• Communicate effectively with other internal departments, external vendors and partners with the goal of achieving the shortest possible time from project inception to product launch and assure submission timelines are met.
• Reporting directly to our Head of Regulatory Affairs.
• You will be required to attend a volunteer event and professional development seminar as part of your internship experience. You will also be assigned a ten (10) to fifteen (15) minute presentation at the end of the internship to express what you learned throughout your time working at Cipla and what you are taking away from the experience

Education Qualifications

• BS degree Pharmacy, Regulatory affairs or related field

Experience

• 0 – 1 year

Skills/ Competencies

• Must be proficient in applicable computer and database applications including MS Word, MS Excel, PowerPoint, PDF etc.
• Ability to manage the timelines.
• Must be well organized, detail orientated, have the ability to multi-task and manage changing priorities.
• Demonstrable applicable knowledge n FDA regulations and FDA/ICH guidelines are also required.
• Demonstrable acceptable skills in oral and written communications, independent judgement, problem solving and effective managing and adhering to timelines.
• MS In Regulatory Science or related fields.

• Demonstrable acceptable skills in oral and written communications, independent judgement, problem solving and effective managing and adhering to timelines.

About CiplaCipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose ‘Caring for Life’, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of 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.InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States.Equal Opportunity EmployerRace, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.

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