Deepthi Govapudi
Oklahoma City
Summary
Regulatory Affairs specialist with experience in regulatory submissions, FDA compliance and eCTD filings for pharmaceuticals. Skilled in CMC documentation, labeling and regulatory strategy. Experienced in working with teams to ensure timely approvals.
Overview
2
2
years of professional experience
Work History
Pharma Regulatory Affairs Research Associate - III
Aurobindo Pharma
08.2023 - 05.2024
- As a regulatory affairs specialist at Aurobindo Pharma , i focused on generic pharmaceuticals in terms of ensuring that the company's products meet all necessary regulatory standards for approval compliance.
- Prepared, compiled and submitted 20+ ANDA's, amendments and supplements to the FDA, ensuring 100% compliance with regulatory guidelines.
- Reviewed and managed eCTD submissions for generic drug products, reducing submission errors by 15%.
- led regulatory strategy development for complex generic products, including first to file (FTF) and paragraph IV applications, resulting in expedited approvals.
- Coordinated with cross functional teams(R&D, Manufacturing) to ensure CMC compliance and timely response to FDA queries.
- Monitored and interpreted FDA regulations to provide guidance on labeling, post market changes and compliance updates, reducing compliance risks.
Pharma Regulatory Affairs
ACME Generics
05.2022 - 06.2023
- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
- Proven ability to learn quickly and adapt to new situations.
- Excellent communication skills, both verbal and written.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Passionate about learning and committed to continual improvement.
- Worked well in a team setting, providing support and guidance.
Education
Master of Science - Pharmaceutical Sciences
Panjab University,Chandigarh,India
India03-2022
Bachelor of Science - Pharmacy
Acharya Nagarjuna University
India05-2020
Skills
- FDA Regulations & Guidelines (IND, NDA, BLA, ANDA, DMF, 510(k), PMA)
- ICH Guidelines (Q1-Q12, E6, M3,etc,)
- Good Manufacturing Practices (GMP, GCP, GLP, GDP)
- Medical Device regulations (21 CFR Part 820, ISO 13485, EU MDR)
- Orphan drug & fast track applications
- Biologicals & Biosimilar regulatory pathways
- Post Market Surveillance & Pharmacovigilance (FAERS, REMS, MedRA)
- Combination products (FDA 21 CFR Part 4, EMA Guidelines)
- Regulatory advertising & promotion (OPDP,DTC,MLR review)
- Controlled substances regulations (DEA, Schedule I - V drugs)
- Electronic Common Technical Document (eCTD) submissions
- Regulatory filing & Submission(IND, NDA, BLA, ANDA,510(k), PMA, DMF, CTD/eCTD)
- Labeling & Package inserts compliance (USPI, SPL, QRD, UDI)
- Regulatory writing (Clinical study reports, Investigator brochures, briefing documents)
- CMC (Chemistry, Manufacturing & Controls) compliance
- Lifecycle management & Change control
Regulatory Knowledge & Compliance
Regulatory Submissions and Documentation
- Medical writing & submission dossiers
- Regulatory strategy development
- Risk Management & Benefit - Risk analysis
- Regulatory intelligence and competitive analysis
- Clinical Trial regulatory Support (Protocol review, CTA, IND amendments)
- Cross-functional team coordination (R&D, QA, Manufacturing, Marketing)
- Microsoft Office (Excel, Word, Powerpoint)
- Data analysis & Visualization (Python - if applicable)
- Attention & detail accuracy
- Strong written & verbal communication
- problem solving & critical thinking
- Time management & Multitasking
- Adaptability to Regulatory changes
- Team collaboration & leadership
Project management & Cross functional Collaboration
Software & Tools
Soft Skills
Timeline
Pharma Regulatory Affairs Research Associate - III
Aurobindo Pharma
08.2023 - 05.2024
Pharma Regulatory Affairs
ACME Generics
05.2022 - 06.2023
Master of Science - Pharmaceutical Sciences
Panjab University,Chandigarh,India
Bachelor of Science - Pharmacy
Acharya Nagarjuna University
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