Director - Regulatory Affairs - Pharma

Job Summary:

Define regulatory strategy to support business in a very dynamic regulatory environment; ensure seamless execution of regulatory plan to support businesses for India and South Asia Countries; Supervise overall regulatory compliance to meet internal and external requirements; Being a strong leader to understand regulatory environment and build up partnership with regulators; Develop a solid RA organization with rationalized resources and streamlined process; Manager communication internal and external in a decent manner.

Key Responsibilities:

- Being a senior leader to develop solid RA strategy and ensure flawless execution of all local regulatory affairs and regulatory compliance requirements

- Plan and drive towards achieving company vision, objectives and dept. strategy with consistent follow up, tracking and feedback

- Provide strategic guidance for product development and planning throughout the product lifecycle

- Define solid RA strategy and plan based on deep understanding of the regulatory environment and business dynamics

- Assist in global and regional regulatory strategy development as and when required.

- Provide regulatory intelligence and manage internal process to share regulatory landscape change and drive needed attention and action from internal stakeholders.

- Identify internal knowledge sharing opportunities across the company through training, practice sharing and other capacity building programs.

- Lead interactions with regulatory authorities related to regulation, policies, guidelines, and QMS requirements

- Support business initiatives regarding maintaining business base and enabling new business growth opportunities

- Develop RA talent and build-up excellence culture in RA organization

Desired Criteria:

- Education Background: B.Sc./ B. Pharma / Engineering /Regulatory Affairs

- 5 years senior RA leader experience in a well-established MNC life science/pharma/medical device/medical diagnostic company, prefer device related

- 5 years people management experience with intelligent and seasoned direct reports.