IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Post : Regulatory Affairs Manager
Job Description :
• Represent International region in Global Regulatory Team and other cross-functional forums, for assigned products
• Develop International regulatory strategies and filing plans, in partnership with the Global Regulatory Lead, and country leads, for assigned products in development
• Plan and create a core dossier for International, in partnership with cross-functional teams, for assigned products
• Develop regulatory strategies in assigned countries, in partnership with local Regulatory teams
• Manage, plan and direct all aspects for the successful preparation, submission and timely approval of marketing applications and post-approval management for assigned countries
• Provide strategic guidance on regulations and changes in assigned countries
• Support interactions with Health Authorities in assigned countries
Candidate Profile
Education/Learning Experience/Work Experience
• A University Degree in Life Sciences is required with 5 to 7 years of industry experience, of which at least 3 years of experience within Regulatory Affairs (registration, development, maintenance)
• Experience of regulatory requirements in countries outside the US and Europe
• Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset
• Experience from leading projects and cross-functional teams
Personal Attributes
• A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds
• Highly self-motivated and able to drive activities
• Excellent communication skills
• The suitable candidate should demonstrate the values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership
• Ensure exemplary behaviour, ethics and transparency within the Company and with regulatory agencies
Additional Information
Experience : 5 to 7 years
Qualification : University Degree in Life Sciences
Location : Bangalore
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September, 2023
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