Regulatory Affairs Intern - Summer 2024 - Princeton New Jersey

Company: Disability Solutions
Location: Princeton, New Jersey
Posted On: 04/19/2024

At Dr. Reddy's "Good Health Can't Wait" By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. At Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.Purpose Dr. Red dy's is seeking a 2025 graduate to hire as a Regulatory Intern to assist with regulatory data management, digitization, and automation . The role will enable the applicant to gain familiarity with diverse areas within regulatory affairs and understand different types of regulatory filings over the lifecycle of drug products.Responsibilities:--- Research and collect analytics for all MUST WIN products per competitor approval dates , filing approval timelines compared to DRL.--- Create SOP for Puerto Rico registrations.--- Review SOP matrix for RA and finalize the actual matrix per RA roles and responsibilities.--- Review clinical database s for all the ongoing clinical trials and compile data for the biologics/ biosi milars pipeline products .--- Collect, review and c reat e databases [ Facilit ies, DMF s ] for the recent filed and upcoming fil ings .--- Creat e ANDAs sequence trackers with summary of the modules submitted and post approval commitments.--- Review , compar e and summary preparation for recently published Regulatory Guidance .--- Gathe r and analyze data for all upcoming submissions/launches with reference to agency's guidance such as Product Specific Guidance , Orange Book and Reference Listed Drug label .--- Review and an alyze the Controlled Correspondence re sponses received for complex molecules and upcoming filings .Qualifications/Skills:--- Pursuing an undergraduate or graduate degree from an accredited US-based University in any Science discipline.--- Proficient communication skills.--- Ability to quickly grasp and learn about the work assigned by team members.--- Knowledge of various regulatory filing types and submission formats.--- A basic understanding of FDA regulatory requirements is a plus.Preference will be given to candidates who are currently pursuing programs focusing on Regulatory Affairs or any other relevant areas in the pharmaceutical field.*Hybrid Work Schedule (3 days on-site, 2 days remote) .Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age (over 40), sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. More...

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