Website IQVIA
About IQVIA
IQVIA is indeed a leading company in the field of human data science, with a strong focus on assisting healthcare clients in discovering valuable insights and improving solutions for patients. The company was created as a result of the merger between IMS Health and Quintiles, two prominent players in the healthcare industry. IQVIA offers a wide array of solutions that leverage the potential of healthcare data, domain knowledge, cutting-edge technology, and advanced analytics to advance the healthcare sector. Their mission is to drive innovation and progress in healthcare through their expertise and resources.
Regulatory Affairs Manager
Job Description:
- Global Representation: Representing the International region in Global Regulatory Team and cross-functional forums for assigned products.
- Strategic Planning: Developing International regulatory strategies and filing plans in partnership with Global Regulatory Lead and country leads for products in development.
- Dossier Preparation: Planning and creating a core dossier for International, collaborating with cross-functional teams for assigned products.
- Country-specific Strategies: Developing regulatory strategies in assigned countries in coordination with local Regulatory teams.
- Application Management: Managing, planning, and directing all aspects of successful marketing application preparation, submission, and timely approval, along with post-approval management for assigned countries.
- Regulatory Guidance: Providing strategic guidance on regulations and changes in assigned countries.
- Health Authority Interaction: Supporting interactions with Health Authorities in assigned countries.
Candidate Profile: Education and Experience:
- Qualification: A University Degree in Life Sciences is required.
- Industry Experience: 5 to 7 years of industry experience, with a minimum of 3 years in Regulatory Affairs (registration, development, maintenance).
- International Focus: Experience with regulatory requirements in countries outside the US and Europe.
- Language Skills: Proficiency in written and oral English is required; knowledge of other languages is advantageous.
- Project Leadership: Experience in leading projects and cross-functional teams.
Personal Attributes:
- Team Collaboration: Strong team player with the ability to work effectively across diverse cultural, seniority, and functional backgrounds.
- Self-Motivation: Highly self-motivated and capable of driving activities independently.
- Communication: Excellent communication skills.
- Values: Demonstrates values such as care for patients, colleagues, and the company, along with ambition, urgency, ownership, and partnership.
- Ethical Conduct: Ensures exemplary behavior, ethics, and transparency within the Company and when dealing with regulatory agencies.
Additional Information:
- Experience Required at IQVIA: 5 to 7 years
- Qualification Required at IQVIA: 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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