Mercy Evangeline Lankapalli
@mercyevangelinelanka
Detail-oriented Drug Regulatory Affairs professional with 4+ years experience.
What I'm looking for
I am a highly motivated Drug Regulatory Affairs professional with over four years of experience in globally recognized firms. My expertise lies in managing product lifecycles, ensuring compliance, and preparing regulatory submissions across various international regulations. I have a proven track record of collaborating across departments to expedite approval processes, ensuring regulatory alignment, and streamlining submission processes.
Throughout my career, I have successfully submitted and secured approvals for 20 global regulatory filings, significantly expediting product market entry. My ability to communicate effectively has allowed me to liaise with cross-functional teams and regulatory agencies, enhancing compliance and reducing approval timelines. I am committed to meticulous documentation and adherence to guidelines, which has resulted in a 100% approval rate in my submissions.
Experience
Work history, roles, and key accomplishments
CMC Ancillary Documentation Specialist
Takeda, Freyr Software Services Pvt Ltd
Aug 2023 - Nov 2024 (1 year 3 months)
As a CMC Ancillary Documentation Specialist, I processed CMC module 1 document requests, ensuring compliance with SME requirements. I coordinated with stakeholders to complete requests on time and proposed solutions to reduce delays by 40%.
Associate in Medicinal Products Regulatory Affairs
Freyr Solutions
Mar 2023 - Nov 2024 (1 year 8 months)
In my role as an Associate in Medicinal Products Regulatory Affairs, I handled regulatory submissions, developed regulatory strategies, and ensured compliance with FDA, EMA, and MHRA guidelines for various countries.
Drug Regulatory Affairs Executive
Alchemy Medicine Private Limited
Jan 2021 - Feb 2023 (2 years 1 month)
As a Drug Regulatory Affairs Executive, I focused on regulatory submissions and compliance with international guidelines, managing documentation for NDAs, ANDAs, and other regulatory filings.
Education
Degrees, certifications, and relevant coursework
Hindu College of Pharmacy
Master of Pharmacy, Drug Regulatory Affairs
2017 - 2019
Grade: 9.5/10
Completed a Master of Pharmacy in Drug Regulatory Affairs with a GPA of 9.5/10, achieving First Class with Distinction.
St. Mary’s Group of Institutions
Bachelor of Pharmacy, Pharmacy
2013 - 2017
Grade: 7.1/10
Earned a Bachelor of Pharmacy with a GPA of 7.1/10, graduating with First Class with Distinction.
Availability
Location
Authorized to work in
Skills
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