Amarjyoti Kalita

Amarjyoti Kalita
Highly motivated and dedicated professional with a master's in Pharmaceutical Regulatory affairs,
Highly motivated
scientific and dedicated
aptitude, and an professional with acombined
eye for detail master's in Pharmaceutical
with a passion Regulatory affairs, scientific
for continuous aptitude, and an eye for detail
learning,
combined with a passion for continuous learning, improvement, and communication, I thrive on the opportunity to assume responsibility for
improvement,
safeguarding publicand communication,
health I thrive
by ensuring the quality on the opportunity
of pharmaceutical tomeeting
products and assume responsibility
all regulatory for
requirements. I am eagerly poised to
safeguarding public
leverage my skills health experience
and extensive by ensuringin a the
new quality
role that of pharmaceutical
allows products
me to continue making and impact
a crucial meeting allpharmaceutical industry.
in the
regulatory requirements. I am eagerly poised to leverage my skills and extensive experience in a
new role that allows me to continue making a crucial impact in the pharmaceutical industry.

Bangalore www.linkedin.com/in/amarkalita-65720279
Bangalore // Homebased,
Homebased, India
India www.linkedin.com/in/amarkalita-65720279

WORK EXPERIENCE SKILLS

Academic Internship Regulatory Affairs (USFDA)
Steriscience
03/2023 – 08/2023 Bangalore
Achievements/Tasks
• Having good knowledge of cGMP, ANDA MAPP. ICH Q1, Q3, Q6 and M2
• Reviewed DMFs for compliance with FDA regulations
• Experienced in eCTD activity in Educe application.
• Submitted CBE 0 and CBE 30
• Submitted PADER reports and Annual reports. Veeva PromoMats
• Maintain database activity
• Knowledge of Submission of Control Correspondence
• Knowledge of the generation of GDUFA cover sheet.

Associate Manager (Global Data Management) EDUCATION

Elanco Innovation and Alliance Centre India LLP
07/2019 – 05/2021 Bangalore Masters in Pharmaceutical Regulatory Affairs
Achievements/Tasks RGUHS
2021 - 2023, Bangalore
• Business visit, presented in Data Management meetings in the USA Bachelor in Pharmacy
• Ensured data entry completeness and validation with good quality RGUHS
• Discrepancy Management / Query Management 2012 - 2016, Bangalore
• Conducted Team Meetings/prepared metrics for higher management
DISSERTATION WORK
• SAE data reconciliation.
Scope of Artificial Intelligence-based Software as a
• External data reconciliation.
Medical Device – A study of regulations as per
• Prepared SOPs and checklists for the data management process
USFDA
• Built CRF for multiple studies
• Handled multiple Studies independently
• Performing UAT according to the test plan. LANGUAGES
• Escalating problems to the attention of the group manager.
Bilingual- Fluent in English (speaking and writing);
• Support electronic archiving activities for multiple documents. Hindi (speaking and writing); Assamese (speaking)
• Provided training to new team members.
• Support the scientific disclosure process
• Support the quality function (TrackWis)

1
WORK EXPERIENCE CERTIFICATIONS
Associate Manager (Global Data Management) 1. Time Management Tips: Communication
Eli Lilly Services India Private Limited (LinkedIn)
2. Body Language to Help Your Business
05/2018 – 07/2019 Bangalore
Carriers (UDEMY)
Achievements/Tasks
3. General Course on Intellectual Property
• Understanding operating procedures and working instructions from (WIPO)
• Provided inputs in the Data Management Plan. 4. Efficient Time Management (LinkedIn)
• Ensured data entry completeness and validation with good quality 5. Communicating with Confidence
• Reviewed and resolved discrepancies identified as per guidelines. (LinkedIn)
• Raises flags and queries for erroneous data or outliers. 6. Pharmacopeial Analysis (USP)
• Resolves queries to expedite data finalization and database lock.
• Query management, Vendor data reconciliation INTERESTS
• QC Process - within and across teams
1. Travelling
• Metrics preparation using intermediate to Advanced MS Excel skills
2. Sports
• Mentoring -Train new team members
3. Gym

Internship (Global Data Management)

Eli Lilly Services India Private Limited
05/2017 – 05/2018 Bangalore
Achievements/Tasks
• Expertise in developing and managing databases
• Ensure data accuracy and integrity.
• comprehensive understanding of the regulatory requisites.
• Involved in various tasks such as data entry and data QC.
• Performed data cleaning and data validation.
• Conduct team meetings.
• Query management
• SAE and vendor data reconciliation.

Place: Bangalore Amarjyoti Kalita

Date: 08/11/2023