Rajeev Agarwal
Deputy General Manager@ Viatris
Hyderabad, Telangana, India
View Rajeev Agarwal's Email
View Rajeev Agarwal's Email & Phone
Real-Time AI Research
0 search queries left
FlashIntel GPT
Hello! I'm FlashIntel GPT, your personal AI search assistant. Feel free to ask me anything about Rajeev Agarwal, and I'll do my best to assist you.
You

Tell me more about Rajeev Agarwal?

FlashIntel GPT

Rajeev Agarwal is a dynamic and result-driven professional with 18 years of experience in regulatory affairs, clinical trials, medical affairs, and regulatory submissions. He has a strong background in the pharmaceutical industry and is skilled in identifying resource needs and tasks within business priorities. Rajeev has worked in various roles, including Deputy General Manager at Viatris and Assistant General Manager at Mylan. He is known for his ability to coordinate with regulatory stakeholders and ensure timely approval and launch of new registration dossiers. Rajeev is also experienced in pre-registration, post-registration, and life cycle management.
For inquiries about Phone Number and Email, please click here Unlock Contact

Research Details
Skills & Insights
Colleagues

Emails and Phone Numbers

@viatris.com
@mylan.in
@gmail.com
View Emails and Phone Numbers
10 free lookups per month

About

Dynamic and result-driven, Clinical, Regulatory (CMC) professional with 18+ years of continuous advancement and expertise in:Primary function/objective:•To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.•Identifies resource needs and tasks within business priorities.•Regulatory Affairs interface with country regulatory stakeholders of the assigned marketsCore Job Responsibilities1. Pre-registration activity: Involved in registration of dossiers to Middle East, North Africa, Russia, Mexico, Turkey and South Africa including Registration. Post Registration activity: Renewals and variations etc. Ensure smooth operation of Regulatory by planning, review and co-ordination for the submission of:• New registration dossiers filing. To communicate and coordinate with different stakeholders to resolve any delay in submission.• Deficiency management: Timely response of the deficiencies raised by the Agency. With this timely approval and launch can be planned.• Life cycle management i.e renewal and filing of variations. • Evaluate change control and provide regulatory input including variation category, data expectation expected approval time and expected implementation of proposed change.• Manufacturing Site registration/Re-registration (Renewal of site registration).• Coordinate with launch team for launch of budgeted products. Ensure compliance at manufacturing location(s) by providing / or updating approval packages of drug products. • Co-ordinate with Pharmacovigilance team for PSUR and RMP as applicable.• Enlighten the regulatory knowledge of subordinates by providing on job training.Due diligence of 3rd Party dossiers: Due diligence of 3P products for Asia, Middle East, North Africa, Africa, Latam, Mexico and South Africa markets.

...See More

Work Experience

Pittsburgh, Pennsylvania, US

Pharmaceutical Manufacturing

15143
Show More

Rajeev Agarwal's Professional Milestones

  • Senior Manager Regulatory Affairs (2015-12-01~2019-02-01): Streamlined regulatory processes, resulting in improved efficiency and accuracy in compliance measures.
  • Research Associate (2004-03-01~2006-02-01): Conducted groundbreaking research for scientific advancements, advancing knowledge and advancing scientific knowledge.
Show More

Education

Punjabi University
Punjabi University

Pharmacology

2000-2003
Show More