Regulatory Affairs Intern - Summer 2024
Company: Disability Solutions
Location: Princeton
Posted on: April 18, 2024
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Job Description:
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.
Keywords: Disability Solutions, Levittown , Regulatory Affairs Intern - Summer 2024, Other , Princeton, Pennsylvania
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