Job opportunity as Head of Regulatory Affairs India at Takeda Pharmaceutical – Apply before 30th September, 2024

About Takeda Pharmaceutical
With over 30,000 employees across 70+ countries, Takeda Pharmaceutical Company Limited is dedicated to improving patients’ lives. As a global, research-driven organization, we collaborate with internal and external partners to translate cutting-edge science into life-changing medicines. Our key focus areas include oncology, gastroenterology, neuroscience, and vaccines that combat the most critical infectious diseases.

Position Overview
As the Head of Regulatory Affairs, India, you will play a pivotal role in shaping the regulatory strategy for Takeda’s product portfolio. Reporting directly to the General Manager of Takeda India, you will lead the local Regulatory Affairs team and ensure compliance with all regulatory requirements while contributing to our mission to introduce innovative treatments to address unmet medical needs. This is a high-impact leadership position crucial to accelerating Takeda’s expansion and presence in India.

Key Responsibilities

• Lead the regulatory strategy for product registration, licensing, and lifecycle management.
• Oversee new product registrations, license renewals, and variations, ensuring timely approvals.
• Ensure compliance with Indian regulatory authorities (DCGI) and maintain updated regulatory files.
• Develop regulatory project plans aligned with global, regional, and local strategies.
• Liaise with internal stakeholders, such as Franchise and CMC Regulatory Affairs, to ensure alignment.
• Provide leadership in regulatory strategy implementation and communicate requirements for licensing.
• Manage relationships with national and regional regulatory bodies and key stakeholders.
• Lead and mentor the local Regulatory Affairs team, fostering a high-performance culture.

Candidate Requirements

• A minimum of 10+ years in Regulatory Affairs within the pharmaceutical, healthcare, or other regulated industries.
• 5+ years in a leadership or managerial role, with experience leading regulatory strategies for product approvals and launches.
• Proven track record of successful regulatory submissions and interactions with authorities (DCGI, Ministry of Health, NPPA).
• A thorough understanding of the Indian regulatory landscape, including ICH guidelines.
• Bachelor’s degree in Science or a related discipline.

Key Competencies

• Strategic Thinking: Ability to see beyond immediate tasks and align strategies for broader organizational goals.
• Collaboration & Influence: Fosters teamwork and creates an environment for collaborative problem-solving.
• Driving Results: Focuses on key priorities and delivers high-impact outcomes.
• Innovation & Leadership: Inspires teams and identifies future leaders, driving change and innovation in the regulatory domain.

Additional Information

• Experience: 5+ years in a regulatory role
• Location: Gurgaon, India
• Industry Type: Pharmaceutical/Healthcare/Clinical Research
• Functional Area: Regulatory Affairs
• Application Deadline: 30th September 2024

Join us in shaping the future of healthcare and make a meaningful difference in patients’ lives. Apply today!