Director - Regulatory Affairs - Pharma

Director Regulatory

The Regulatory Affairs Director for a large MNC based in Mumbai

He will provide leadership and direction to the India Regulatory Function. He / she will develop the Regulatory strategy for India and ensure internal alignment and external stake holder management in execution of strategy and achieving company Objectives.

Core Job Responsibilities :

- Define the regulatory strategy and structure aligned with the overall India strategy

- Oversee all India regulatory projects

- Responsible and accountable for the delivery of agreed objectives of all staff within regulatory, within guidelines, laws and general practices

- Maintain India global marketing authorizations in compliance

- Guide strategies to influence changing regulations and guidance

- Provide executive management with regulatory metrics, information and trends.

- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions

- Manages and oversees interactions with DCGI, Trade Associations and key opinion leaders

- Develop and advance the organization's policy and procedures for regulatory affairs and compliance to establish a compliant culture

- Manage the India regulatory budget (approx. XXX)

- Decide/approve commitments with external consultants and service vendors

- Guide and lead India regulatory function, ensuring safety compliance and patient safety for all products under the scope of legal entities

- As member of India senior staff, contribute to the overall goals and facilitate and promote cross-functional collaboration and Global to Affiliate collaboration.

- Provide senior regulatory voice and leadership in external collaborations, participate in L&A activities and lead appropriate functional integration in acquisitions of products or organizations.

- Forge partnerships & effectively collaborate with other functions like Government Affairs, Quality Assurance, Supply Chain, R&D and commercial organization.

- Build a strong & performing team.