AstraZeneca is a global, science-driven biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines to treat some of the world’s most serious diseases. With a strong commitment to patient care, AstraZeneca operates in over 100 countries, delivering life-changing therapies while fostering an inclusive and collaborative work environment.
Job Description: Executive Regulatory Affairs
AstraZeneca is seeking a highly motivated Executive Regulatory Affairs professional to join its team in Mumbai. This role involves managing regulatory submissions, ensuring compliance with Indian regulations, and supporting new product launches.
Key Responsibilities:
- Monitor and report the status of all product licenses.
- Support the team in implementing submission plans for new products and maintaining existing licenses.
- Manage SUGAM submissions and ensure timely regulatory approvals.
- Prepare and respond to Health Authority queries efficiently.
- Maintain Regulatory trackers and ensure proper documentation.
- Handle submissions for test licenses, clinical trial updates, and tender requirements.
- Collaborate with cross-functional teams (Marketing, Sales, Medical, Supply Chain, etc.).
- Ensure compliance with local and global regulatory policies.
- Support artwork reviews, import licenses, and clinical trial submissions.
- Provide guidance to junior team members and new hires.
Minimum Requirements:
- Education:Â M.Pharm / B.Pharm / M.Sc
- Experience: 2-3 years in India Regulatory Affairs (pharma industry preferred).
- Skills Required:
- Knowledge of dossier compilation and Indian regulatory guidelines.
- Strong project management and communication skills.
- Ability to work independently with minimal supervision.
Why Join AstraZeneca?
- Innovative Work Environment:Â Be part of a company that pushes the boundaries of science.
- Career Growth:Â Opportunities for continuous learning and professional development.
- Inclusive Culture:Â A workplace that values diversity, collaboration, and employee well-being.
- Global Impact:Â Contribute to life-changing medicines that benefit patients worldwide.
