Associate Regulatory Affairs
Dr. Reddy’s Laboratories Ltd, Lincoln, NE, United States
Job Description
We are seeking an Associate Regulatory Affairs for our North America business. The incumbent will be responsible for maintenance and tracking of regulatory documentation and information pertaining to life cycle management activities; assisting in review of CMC documents for supplements, ANDAs, NDAs, DMFs as needed.
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 of post approval changes.
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 and other internal stakeholders.
Assist with due diligence / divestment and gap analysis in consultation with Team Lead.
Review and closure of change notifications (CRNs)/change controls in consultation with Team Lead for under review and launched products.
Provide launch support with regard to regulatory decisions in consultation with Team Lead.
Facilitate interaction with USFDA to seek clarity around issues identified during development, review and launch.
Assist with forms and documentation signoff as assigned by Team Lead; handle CDER portal submissions/FOI requests.
Maintain/archival regulatory folder for assigned products.
Assist and track Establishment Registration, Facility Self-identification, Annual GDUFA fee program, PDUFA Program Fee, Facility Fee.
Assist with annual volume reporting and Drug Listing for both Drug Substances and Drug Products as per GDUFA.
Perform regulatory SOP and training activities on an as needed basis.
Qualifications
Educational qualification:
Degree in Pharma
Experience:
3 to 5 years of experience working in regulatory affairs on new and or post approval submissions for ANDA.
Skills & attributes:
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 is highly preferred.
Ability to understand and communicate issues noted in submissions.
Ensure appropriate maintenance of regulatory document files.
Excellent organizational, time‑management and prioritization skills needed to manage multiple ongoing projects simultaneously.
Ability to work with a diverse cultural group.
Effective communication skills (oral and written).
Time management and multitasking.
Incumbent should be willing to work in person from our Princeton, NJ office.
Additional Information
Must be a U.S. citizen or lawful permanent resident of the U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.
Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process.
Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
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We are seeking an Associate Regulatory Affairs for our North America business. The incumbent will be responsible for maintenance and tracking of regulatory documentation and information pertaining to life cycle management activities; assisting in review of CMC documents for supplements, ANDAs, NDAs, DMFs as needed.
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 of post approval changes.
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 and other internal stakeholders.
Assist with due diligence / divestment and gap analysis in consultation with Team Lead.
Review and closure of change notifications (CRNs)/change controls in consultation with Team Lead for under review and launched products.
Provide launch support with regard to regulatory decisions in consultation with Team Lead.
Facilitate interaction with USFDA to seek clarity around issues identified during development, review and launch.
Assist with forms and documentation signoff as assigned by Team Lead; handle CDER portal submissions/FOI requests.
Maintain/archival regulatory folder for assigned products.
Assist and track Establishment Registration, Facility Self-identification, Annual GDUFA fee program, PDUFA Program Fee, Facility Fee.
Assist with annual volume reporting and Drug Listing for both Drug Substances and Drug Products as per GDUFA.
Perform regulatory SOP and training activities on an as needed basis.
Qualifications
Educational qualification:
Degree in Pharma
Experience:
3 to 5 years of experience working in regulatory affairs on new and or post approval submissions for ANDA.
Skills & attributes:
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 is highly preferred.
Ability to understand and communicate issues noted in submissions.
Ensure appropriate maintenance of regulatory document files.
Excellent organizational, time‑management and prioritization skills needed to manage multiple ongoing projects simultaneously.
Ability to work with a diverse cultural group.
Effective communication skills (oral and written).
Time management and multitasking.
Incumbent should be willing to work in person from our Princeton, NJ office.
Additional Information
Must be a U.S. citizen or lawful permanent resident of the U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.
Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process.
Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
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