Lavanya Pillutla
Boston,MA
Summary
Motivated Regulatory Affairs enthusiast seeking a co-op opportunity. Committed to excellence with a strong academic background, I bring determination and analytical skills to navigate complex regulations. Eager to contribute to your team's success and ready to tackle real-world challenges. Positioned to make an immediate impact and support regulatory efforts.
Overview
1
1
years of professional experience
1
1
Certification
Work History
Academic Projects
Development of Basic Study protocol (October 2023)
- Conducted global Phase III clinical trial sponsored by Lupin to compare effectiveness and safety of LUBT010 and Lucentis in neovascular age-related macular degeneration (AMD) treatment.
- Employed rigorous recruitment and informed consent procedures, targeting AMD patients aged 50 and above with CNV lesions through medical clinics and online platforms.
- Implemented standardized treatment with intravitreal injections and meticulous data collection via examinations and assessments.
Development and commercialization of magic dust (July 2023 to August 2023)
- Led cross-disciplinary team for innovative "magic dust" pharmaceuticals, advancing antipyretic, antiseptic, and antihistaminic solutions through successful development and regulatory approvals.
- Expertly managed FDA meetings and intellectual property concerns, ensuring safe and compliant pharmaceutical formulations.
- Drove market success by optimizing pricing and reimbursement strategies with strong data-driven approaches in pharmaceutical and healthcare sectors
.
Formulation and evaluation of thermo reversible gels for an ocular drug delivery (July 2023 to August 2023)
- Advancing Clarithromycin drug delivery in ophthalmic care via responsive in situ forming gels.
- Improving bioavailability and therapeutic impact through innovative gel-based solutions.
- Overseeing a comprehensive project from development to rigorous testing for safe and effective drug delivery
Development and Commercialization of Magic Dust
07.2023 - 08.2023
- Led cross-disciplinary team for innovative "magic dust" pharmaceuticals, advancing antipyretic, antiseptic, and antihistaminic solutions through successful development and regulatory approvals.
- Expertly managed FDA meetings and intellectual property concerns, ensuring safe and compliant pharmaceutical formulations.
- Drove market success by optimizing pricing and reimbursement strategies with strong data-driven approaches in pharmaceutical and healthcare sectors.
Development of Basic Study Protocol
07.2023 - 08.2023
- Led cross-disciplinary team for innovative "magic dust" pharmaceuticals, advancing antipyretic, antiseptic, and antihistaminic solutions through successful development and regulatory approvals.
- Expertly managed FDA meetings and intellectual property concerns, ensuring safe and compliant pharmaceutical formulations.
- Drove market success by optimizing pricing and reimbursement strategies with strong data-driven approaches in pharmaceutical and healthcare sectors
Charity Organisation Coordinator
NiSWArdha Charity Organisation
03.2016 - 09.2020
- Oversee fundraising strategies, campaign execution, and event coordination to secure funds for organizational initiatives.
- Manage volunteer recruitment, training, and supervision, aligning their efforts with the organization's mission.
- Cultivate partnerships with donors, sponsors, and other entities to secure funding and support collaborative efforts.
- Coordinate community outreach initiatives to raise awareness and garner support for the charity's cause.
- Handle administrative tasks, including budget management and regulatory compliance
Education
G.P.A -
Northeastern University
Boston, MAMaster of Sciences - Regulatory Affairs
Coursework: Introduction to food -
administration, Regulatory Compliance -
Bachelor of pharmacy -
Acharya Nagarjuna University
Skills
- TECHNICAL SKILLS
- Regulatory: Understanding of FDA, Quality Assurance, IND (21 CFR 312), NDA (21 CFR 314), ANDA,BLA(21 CFR 6012)
- 510(K), PMA,GCP (21
- CFR 820), ISO14971, ICH guidelines, CAPA, Quality Inspection, Quality Review, RIMS, GMP ( 21 CFR 201
- 211),Auditing, CTD, eCTD, Regulatory Strategies, Quality Compliance, Regulatory Submission, Dossier and Documentation
- Quality System Regulations, Computer System Validation ( IQ,OQ,PQ), 21
- CFR 11, 21 CFR 50, 21 CFR 56, ICH E6(R2), MDR, De
- Novo, IDE, QSR (21 CFR820)
- Additional Application: MS Word, MS Excel, Microsoft PowerPoint, Adobe
- Soft Skills: Communication skills, Analytical Skills, problem solving, Time management, organizational skills, Team spirit
Accomplishments
- Certifications: FDA role in post marketing surveillance (October 2023), MS office (November 2023)
Additional Information
- Participations: , Gold Nanoparticles in cancer treatment (October 2018), Pharmaceutical Nano systems and novel applications (August 2017)
Certification
FDA role in Post Marketing Surveillance
Timeline
Development and Commercialization of Magic Dust
07.2023 - 08.2023
Development of Basic Study Protocol
07.2023 - 08.2023
Charity Organisation Coordinator
NiSWArdha Charity Organisation
03.2016 - 09.2020
Academic Projects
G.P.A -
Northeastern University
Master of Sciences - Regulatory Affairs
Coursework: Introduction to food -
administration, Regulatory Compliance -
Bachelor of pharmacy -
Acharya Nagarjuna University