Akhilesh Meshram
Nagpur Maharashtra
Summary
Professional regulatory affairs Associate with a good understanding of the Regulatory Affairs Labeling along with end to end labelling process. Acquired excellent time management and organization skills to handle complex projects. Looking for an exciting position within a reputed organization that allows me to acquire new skills, broaden my understanding, and apply my skills and knowledge effectively. I aim to capitalize on my potential, contribute to the organization's development, and make the most of available opportunities.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Technical Associate, Regulatory Affairs
Genpact India Pvt. Ltd
Hyderabad
07.2022 - Current
- Working within client's global regulatory affairs team.
- Prepare company responses to queries from Health Authorities across USFDA, EMA, MHRA, and ROW.
- Analyze pharmacovigilance database for new signals and integrate safety concepts into company core data sheet (CCDS), USPI, SmPC, and PIL.
- Develop and maintain CCDS, ensuring compliance with global regulations.
- Collaborate with cross-functional teams using platforms like Veeva-Vault and SharePoint.
- Authoring documents, initiating work sharing procedures for products across various countries for the purpose of labeling harmonization with Veeva Vault tool( Cloud management platform) .
- Keeping Veeva records updated.
- Contribute to periodic reports such as PSUR, PSUSA, PBRER and ACO.
Education
M. Tech. - Pharmaceutical Technology Process Chemistry
National Institute of Pharmaceutical Education And Research
NIPER Hyderabad06-2022
B. Pharm -
Gurunanak College of Pharmacy
Nagpur, MH05-2020
Skills
- Excellent communication and Interpersonal skills
- Team oriented approach
- Adaptability and Quick learning
- Proactiveness and self learning
- MS Office proficiency
Certification
- Upskilled with the professional training courses available on Genome, a Genpact’s employee training platform and received the certificate on- Beginner Regulatory Affairs, Beginner Pharmaceuticals Life Sciences and Healthcare, Beginner Energy at Work and Storytelling.
- Participated as a student in International conference on "NextGen Therapeutics and Diagnostic Concepts to Commercialization" organized by NIPER Hyderabad.
Personal Information
- Date of Birth: 08/29/1997
- Gender: Male
Accomplishments
- Hero of the month (June-2023)
- Silver Cheers award for Q3 2023 in the category of Courageous - Appetite
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Affiliations
- Table tennis player
- Bike and car enthusiast
- love to travel
- Listening to music
Timeline
Technical Associate, Regulatory Affairs
Genpact India Pvt. Ltd
07.2022 - Current
M. Tech. - Pharmaceutical Technology Process Chemistry
National Institute of Pharmaceutical Education And Research
B. Pharm -
Gurunanak College of Pharmacy
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