Novumgen Hiring in Regulatory Affairs
Experience :
2 Years
Salary :
3.3 Lakhs – 15.6 Lakhs Per Year
Vadodara
Novumgen Is A Pharmaceutical And Biological Company That Develops, Manufactures, And Supplies Medicines To Patients And Healthcare Institutions. The Company Was Founded By Experienced Pharmaceutical Professionals Who Are Constantly Working To Develop Innovative Healthcare Products That Benefit Both Patients And Prescribers
Position:
Executive / Sr. Executive – RA
Department:
Regulatory Affairs
Education:
B.Pharm, M.Pharm, M.Sc, B.Sc, Lifesciences
Job Lcation :
Vadodara
Job Description
[email protected]
Serve As The Regulatory Expert Responsible For Submissions, Requests For Information (RFIs), And Compliance Activities For Pharmaceutical Development And Commercial Products Supporting The Business Unit.
Lead The Preparation Of Chemistry, Manufacturing, And Controls (CMC) Information For Submission To Global Regulatory Agencies, Develop And Execute CMC Strategies, Assess Risks, And Formulate Mitigation Plans.
Provide Regulatory Direction And Documentation For Assigned Projects/Products, Covering Initial Registrations And Approval/Post-Approval Activities, Particularly For Regional Products Registered For EU/AU/CA/UK Markets.
Act As The Global Regulatory Representative Within Cross-Functional Teams, Interpreting Regulations And Guidelines And Assessing Global Implications For Strategic Regulatory Decisions.
Responsible For Interactions With Regulatory Agencies And External Partners, Either Directly Or In Collaboration With Other Stakeholders.
Independently Resolve Issues, Manage Regulatory Risks, And Navigate Ambiguous Situations Within Project Teams.
Explore Opportunities For Regulatory Innovation And Advocate For The Use Of Novel Approaches Within Project Teams To Address Issues And Challenges. May Take Calculated Risks To Achieve Desired Outcomes.
How To Apply:
Interested Candidates Can Share Their CV To [email protected]
Last Date: 30th April 2024
https://chat.whatsapp.com/DO9PMPj2H3K4SikyHri52x
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