AVP - Regulatory - Pharma

- Manage regulatory functional support for India, SAAR Countries (Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka) and Iran.

- Review and maintain regulatory documents and files (including product label, promotional materials, manufacturing change requests, and registration packages); record product filings, approvals, and registration activities.

- Develop strong connections with regulators and industry associations/standards to gain insights on upcoming changes of regulations

- Coordinating regulatory activities including development, presentation, and review of required regulatory documents in support of product registrations

- Ensure requirements for effective approvals and registrations are met in a timely matter.

- Support submission/filing projects and implement strategies to address issues throughout the filing process.

- Prepare registration packages in line with local regulatory requirements and guidelines.

- Participate in and contribute to decisions in cross-divisional team meetings; participate in preparing regulatory strategies.

- Gather regulatory intelligence that is relevant to company portfolio and disseminate as appropriate

- Maintain close relationship with government authorities and test institutes