Job Description
Job Description:
Job Summary**
The Senior Manager - Regulatory Affairs will lead and manage regulatory activities for assigned products and projects, ensuring compliance with Indian and South Asian regulations and strategic alignment with business objectives. This role also will support the Pharmacovigilance activities. This role requires a proactive and adaptive individual capable of driving regulatory strategy and fostering effective relationships with regulatory bodies.
Job Responsibilities**
* Develop, implement, and maintain global regulatory strategies for assigned products throughout their lifecycle.
* Lead and manage regulatory submissions, including initial applications, variations, renewals, and responses to agency queries, ensuring timely and high-quality deliverables.
* Oversee and manage change control processes related to regulatory documents and submissions.
* Act as the primary point of contact for int...