Rajeev Agarwal
Punjabi University
Tell me more about Rajeev Agarwal?
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.
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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 MoreWork Experience
Deputy General Manager
Pharmaceutical Manufacturing
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.
Education
Pharmacology
2000-2003Skill
Regulatory Affairs
Clinical Trials
Medical Affairs
Regulatory Submissions
Pharmaceutical Industry
Anda
Pharmaceutical Research
Regulatory Filings
Regulatory Requirements
Abbreviated New Drug Application
Clinical Development
Pharmacokinetics
Generic Programming
Pharmacovigilance
Ectd
Pharmacology
Pharmaceutics
Certification
Colleagues
Maki Kopp Ph.D
Learning And Organizational Development Franchise Owner
Roberto Gaslini
Chief Financial Officer | Director Of Regulatory Affairs
Susan Calandrella
Senior Director | IP Global Process Owner
S A Konok
Owner at Viatris
John R. Powell
Business Owner
Other Named Rajeev Agarwal
Frequently asked questions
We found 3 Rajeev Agarwal's email addresses
Rajeev Agarwal works for Viatris
Rajeev Agarwal's role in Viatris is Deputy General Manager
Rajeev Agarwal works in the industry of Pharmaceutical Manufacturing
Rajeev Agarwal's colleagues are Maki Kopp Ph.D,Roberto Gaslini,Susan Calandrella
Rajeev Agarwal's latest job experience is Deputy General Manager at Viatris
Rajeev Agarwal's latest education in Punjabi University