Position: Regulatory Affairs Manager II
Location: Bangalore, India
Industry: Pharma / Healthcare / Clinical Research
Application Deadline: 10-Nov-2024
Company Overview
AstraZeneca is a global biopharmaceutical company that significantly impacts healthcare beyond its medicines. In the UK, AstraZeneca has contributed to job creation and economic growth, and it continues to invest in innovation and regulatory approaches to bring life-saving medicines to patients worldwide.
Job Description
The Regulatory Affairs Manager II will work within AstraZeneca’s International Regulatory Affairs Management (RAM) team, playing a key role in delivering international submissions for Marketing Authorisation Applications (MAAs), Clinical Line Extensions (CLEs), and Life Cycle Maintenance (LCM) applications. This position requires a strong regulatory specialist with project management skills to coordinate and execute regulatory tasks across multiple regions efficiently.
Responsibilities
- Regulatory Framework Knowledge: Demonstrate understanding of the regulatory framework for small and large molecules across all international regions.
- Regulatory Documentation: Coordinate and prepare international submission dossiers, including MAAs, CLEs, and LCMs, and contribute to health authority responses.
- Process Leadership: Lead complex regulatory maintenance submissions and ensure timely submission.
- Cross-functional Collaboration: Work closely with cross-functional teams on product responsibilities and maintain submission delivery and content plans.
- Project Management: Update project planning tools, track submissions, and document management, while identifying and managing regulatory risks.
- Mentorship and Improvement: Provide coaching and share knowledge within the international regulatory team, contributing to continuous improvement.
Candidate Profile
Essential Qualifications:
- University Degree in Science or related field.
- At least 8 years of regulatory experience in the biopharmaceutical industry, particularly in international markets.
- Solid knowledge of drug development and new MAA processes.
- Strong project management skills and proficiency with tools like MS Project.
Desirable Qualifications:
- Experience with a variety of international markets.
- Familiarity with Veeva Regulatory Information Management (RIM) systems.
- Experience working with international teams and excellent English communication skills.
- Scientific background for understanding regulatory issues.
Additional Information
- Functional Area: Regulatory Affairs
- End Date: 10-Nov-2024