Associate Regulatory Affairs
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Job Location:
Princeton, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
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 to 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
- Providing launch support w.r.t regulatory decisions in consultation with Team Lead
- Facilitate interaction with USFDA to seek clarity around the issues identified during development review and launch
- Assist with forms and documentation signoff as assigned by Team Lead; handle CDER portal submissions/FOI requests
- Regulatory folder maintenance/archival 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
- 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 U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.
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.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
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.
For more details please visit our career website at Work :
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Dr. Reddys Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Cant Wa ... View more
