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Regulatory Affairs Manager II is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned global deliverables in the maintenance Center of Excellence, as an individual contributor.

Oversee validation and qualification activities related to manufacturing, processes, cleaning, equipment and systems. Ensure effective handling of market complaints, product quality issues and investigations.

B.Pharm, M.Pharm. Quality Assurance Head is a leadership role responsible for ensuring the quality and safety of all products

B.Pharm / M.Pharm / M.Sc. or equivalent qualification in a relevant discipline. Candidates with experience in Oncology/Cytotoxic manufacturing facilities.

Proven track record in a similar role or one level below in a reputed pharmaceutical company. Strong strategic, commercial and execution capabilities. 

Support change management and adoption (training materials, role-based guidance, SOP impacts) and contribute to internal knowledge sharing/mentoring.

Support for conduct of regulatory inspection in collaboration with other R&D stakeholders involved in in-house and outsourced clinical studies.

The role holders effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics) to deliver the needs of both the AZ business and the customer. AstraZeneca

Develop and execute regulatory strategies, providing leadership and guidance on pharmaceutical regulatory requirements across India and South Asia to support product registrations, market access, launches, lifecycle management, and post-market compliance.