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.

Diversity, Equity & Inclusion

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:

The incumbent will provide labeling and publishing support to the Life cycle management team for the assets managed within North America Generics. Based in Princeton, NJ (Hybrid work schedule) the role will report to Lead Associate Regulatory Affairs

Responsibilities:

• Prepare and review all the labeling associated with approved ANDA / NDA per the referenced product labels while adhering to corporate and FDA guidelines
• Assist the team lead / lead associate with strategic inputs/review of post approval changes and identify appropriate filing category for any labeling changes
• Prepare and review labeling modules of supplements and Annual Reports for ANDAs managed by North America Generics
• Prepare / review PIL, container, carton labels, medication guides for Rx and OTC products
• SPL preparation and drug listing
• Support with publishing of original ANDA, Supplements, Annual reports and other typical submissions associated with ANDA / NDA
• Support to internal stakeholders and customers data requests
• Documentation maintenance
• Manage / Monitor for compliance with all registration and reporting activities associated with GDUFA / PDUFA
• Identify and support with automation / digitization activities
• Participate in Promotional Material Review Committee and manage OPDP submissions

Qualifications / Skills:

• 2-5 years’ experience in Regulatory Affairs; BS/MS degree in a scientific discipline preferred
• Prior experience (min 1-2 years) of preparation / review of labeling (Rx and eCTD publishing activity required
• Familiarity with Promotion materials review; eCTD modules and SPL listing
• Familiarity with labeling requirements as listed in 21 CFR
• Familiarity with regulations and guidance published by USFDA pertaining to labeling and eCTD publishing
• GMP requirements in FDA
• Regulatory submission formats and filing categories
• Good understanding of FDA guidance especially post approval changes and reporting classifications
• Strong oral and written communication skills
• Strong collaboration with cross functional teams
• Multi-tasking
• Attention to detail

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.

COVID-19 Vaccination

Getting vaccinated remains the most effective way to halt the spread of the COVID-19 pandemic, and Dr. Reddy’s encourages all employees to be vaccinated. At this time, vaccinations are not mandated for Princeton-based employees but may become required in the future. Weekly COVID testing is mandatory for all employees who have not uploaded proof of vaccination or who are not fully vaccinated.

Equal Opportunity Employer:

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.