AstraZeneca, a leading global biopharmaceutical company, is currently seeking a skilled professional to join our team as an Executive in Regulatory Affairs. Located in the bustling Mumbai Metropolitan Region, this role offers a unique opportunity to contribute to the discovery, development, and commercialization of cutting-edge prescription medicines aimed at addressing some of the most severe diseases facing humanity.
About AstraZeneca
At AstraZeneca, our mission transcends typical pharmaceutical operations. We are committed to scientific innovation and are centered around serving patient needs. Our extensive portfolio represents some of the most significant advancements in medicine, underscoring our leadership within the industry.
Position Purpose
In the role of Executive Regulatory Affairs, your primary responsibilities will encompass monitoring and reporting the status of product licenses effectively. You will ensure that all regulatory submissions—pertaining to new products and maintenance of existing licenses—are executed seamlessly and on schedule.
Key Responsibilities
- Product License Monitoring: Promptly report on the status of product licenses and manage submissions as directed to maintain compliance with regulatory requirements.
- Submission Management: Collaborate with teams to develop and implement submission plans, ensuring timely execution of applications, including test licenses, Health Authority Queries (HAQs), clinical trial updates, and notifications.
- Communication with Authorities: Effectively collate and communicate with health authorities, preparing responses to queries with a comprehensive understanding of regulatory expectations.
- Regulatory Trackers Maintenance: Maintain regulatory trackers and documentation archives meticulously to ensure smooth operational workflows and audit readiness.
- Support Cross-functional Collaboration: Work closely with various internal stakeholders, including Marketing, Sales, Logistics, Medical, and Quality Assurance departments, to advance regulatory objectives.
Internal and External Collaboration
Internal collaboration is crucial to the success of this role. You will interface with numerous teams, including:
- Marketing
- Sales
- Logistics
- Medical Affairs
- Legal and Intellectual Property
- Clinical Operations
- Global Product Teams (GPTs)
- International Regulatory Affairs (IRA)
On the external side, maintaining a professional relationship with local health authorities and government agencies is essential for the efficient handling of compliance and regulatory matters.
Minimum Qualifications
The ideal candidate for this position will possess:
- A degree in M.Pharm, B.Pharm, or M.Sc.
- 2-3 years of experience within the India regulatory framework.
- A comprehensive understanding of dossier compilation and Indian regulations.
Key Result Areas
To ensure success in the Executive Regulatory Affairs role, the following areas will be a focus:
Compliance and Governance
- Adhere strictly to local legislation and global regulatory policies, maintaining high standards of corporate governance.
- Safeguard company confidentiality, including intellectual property and strategic initiatives.
Documentation and Communication
- Maintain accurate documentation records and trackers diligently to ensure compliance and efficiency.
- Proactively communicate any changes to product license statuses and maintain an open dialogue with all relevant parties.
Project Management
- Demonstrate ownership and accountability in managing changes related to product licensing through effective project management skills.
- Track the status of submissions and implement corrective actions promptly to ensure rapid approval timelines.
Why Choose AstraZeneca?
AstraZeneca prides itself on being a Great Place to Work. We foster an environment that empowers employees to explore the frontiers of science while promoting an entrepreneurial spirit. As part of our inclusive culture, we celebrate diversity and encourage collaboration. Our commitment to lifelong learning and professional development ensures that you are always growing in your career.
Join us on this exciting journey to pioneer the future of healthcare. If you are passionate about making a difference in medicine and society, apply for the Executive Regulatory Affairs position today!
In summary, AstraZeneca offers not just a job but a rewarding career path where you can have a tangible impact on the lives of patients around the world. With our robust commitment to innovation and growth, this is an outstanding opportunity for anyone looking to advance their career in regulatory affairs within a reputable organization.
