Associate Regulatory Affairs

1w1 week ago

Dr. Reddy's Laboratories

Princeton, US · Full-time · $90,000 – $120,000

About this role

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. We are seeking a dynamic Associate Regulatory Affairs for our North America business.

The role involves maintenance and tracking of regulatory documentation and information pertaining to life cycle management activities. You will assist in review of CMC documents for supplements, ANDAs, NDAs, DMFs as needed. Responsibilities include providing inputs on post-approval changes to ensure timeliness and quality of submissions.

Support internal stakeholders and customers on data requests by coordinating with India RA teams and other groups. Work in consultation with Team Lead on due diligence, change controls, and launch support. Facilitate interaction with USFDA to seek clarity on development, review, and launch issues.

Join a diverse, equitable, and inclusive workplace where everyone belongs and is valued. We are open to exploring candidates with less traditional backgrounds. Be ready to inspire and make a difference for your community in our Princeton, NJ office.

Requirements

Degree in Pharma
3 to 5 years of experience working in regulatory affairs on new and or post approval submissions for ANDA
Good understanding of Pharmaceutical development, manufacturing processes, analytical, and cGMP requirements with hands on experience of reviewing CMC documents
Basic familiarity with ANDA approval process, submission categories, filing requirements and agency communication
Hands on experience of reviewing analytical methods, validations and reports
Ability to understand and communicate issues noted in submissions
Excellent organizational, time management and prioritization skills to manage multiple ongoing projects
Effective communication Skills (oral and written) and ability to work with a diverse cultural group

Responsibilities

Provide inputs/review of post approval Changes (Supplements PAS/CBE-30/CBE-0 & Annual Reports) for ANDAs and ensure timeliness and quality of compilation, publishing and submission
Support with assigned review of CMC documents for assigned new and LCM products
Support internal stakeholders and customers on data requests by coordinating with India RA teams
Assist with due diligence / divestment and gap analysis in consultation with Team Lead
Review and closure of change notifications (CRNs)/change controls for under review and launched products
Provide launch support w.r.t regulatory decisions in consultation with Team Lead
Facilitate interaction with USFDA to seek clarity around issues identified during development, review and launch
Maintain regulatory folder/archival for assigned products and assist with Establishment Registration, Facility Self-identification, and GDUFA fees

Benefits

Deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs
Open to exploring candidates with a less traditional background