ML
Open to opportunities

Mercy Evangeline Lankapalli

@mercyevangelinelanka

Detail-oriented Drug Regulatory Affairs professional with 4+ years experience.

France
Message

What I'm looking for

I am seeking a role that fosters collaboration, innovation, and professional growth in regulatory affairs.

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

TL
Current

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%.

FS
Current

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.

AL

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

HP

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.

SI

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.

Tech stack

Software and tools used professionally

Find your dream job

Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!

Sign up
Himalayas profile for an example user named Frankie Sullivan
Mercy Evangeline Lankapalli - CMC Ancillary Documentation Specialist - Takeda, Freyr Software Services Pvt Ltd | Himalayas