Regulatory Affairs Lead | Takeda | Gurgaon, Haryana, India
Location: Gurgaon, Haryana, India
Company: Takeda
Department: Research & Development / Regulatory Affairs
Employment Type: Full-Time
Experience Required: Minimum 10 Years (including 2+ Years in Team Management)
Education Required: Bachelor’s Degree in Pharmacy, Life Sciences, or Related Field (Master’s Degree Preferred)
About Takeda
Takeda is a global, research-driven biopharmaceutical company committed to improving patient outcomes and advancing healthcare innovation. Guided by its purpose of creating better health for people and a brighter future for the world, Takeda focuses on discovering and delivering life-transforming treatments for patients worldwide.
With a strong presence in global healthcare, Takeda integrates scientific innovation, regulatory excellence, and patient-centered strategies to develop specialty pharmaceuticals and advanced therapies. The organization promotes a collaborative, inclusive workplace culture where employees are empowered to contribute to scientific advancement and meaningful healthcare solutions.
Job Overview
Takeda is seeking an experienced Regulatory Affairs Lead to oversee regulatory strategy and operations for its pharmaceutical portfolio in India. The role is responsible for developing and executing regulatory strategies for both existing products and pipeline assets while ensuring full compliance with Indian regulatory requirements.
The Regulatory Affairs Lead will play a strategic role in supporting new product registrations, lifecycle management, and clinical trial regulatory activities. The position also requires close collaboration with global and local cross-functional teams to accelerate regulatory approvals and maintain product compliance across the lifecycle.
Key Responsibilities
Regulatory Strategy Development
Develop and implement regulatory strategies for pipeline products and marketed products in India.
Align regulatory plans with global product strategies and local business objectives.
Provide regulatory guidance to cross-functional teams including quality, clinical, medical, safety, supply chain, and legal departments.
Monitor changes in the regulatory environment and proactively identify potential risks and opportunities.
Support regulatory activities related to clinical trial approvals to accelerate development of priority assets.
Regulatory Submissions and Approvals
Prepare and submit high-quality regulatory dossiers in accordance with Indian regulatory requirements.
Coordinate submission timelines and ensure regulatory documentation is complete and compliant.
Manage interactions with Health Authorities to secure product registrations and approvals.
Prepare responses to regulatory queries and ensure timely submission of additional information.
Support product labeling, packaging development, and regulatory documentation updates.
Regulatory Compliance and Lifecycle Management
Ensure ongoing compliance of marketed products with local regulatory requirements and corporate policies.
Manage lifecycle activities including label updates, variations, and regulatory commitments.
Conduct periodic compliance reviews and implement corrective and preventive actions when required.
Develop and maintain Standard Operating Procedures aligned with global regulatory policies and Good Regulatory Practices.
Regulatory Systems and Reporting
Maintain regulatory databases and documentation systems in accordance with local regulatory plans.
Ensure accuracy and completeness of regulatory data and records.
Provide regulatory performance metrics and periodic reports to local and regional leadership teams.
Stakeholder Management
External stakeholder engagement includes establishing relationships with regulatory authorities and industry associations to maintain a constructive regulatory environment. The role requires continuous monitoring of regulatory policy updates and communicating relevant changes to internal stakeholders.
Internal stakeholder collaboration involves working closely with local and global teams to support regulatory decision-making and ensure successful product development and commercialization strategies.
People Leadership and Team Development
Lead, mentor, and develop regulatory affairs professionals within the team.
Support capability development through training, knowledge sharing, and professional development initiatives.
Collaborate with the Country Regulatory Head to strengthen regulatory expertise within the organization.
Required Skills and Competencies
Strong knowledge of Indian pharmaceutical regulatory requirements and submission processes.
Expertise in regulatory documentation, product registrations, and lifecycle management.
Experience working with regulatory systems and platforms such as Veeva or other regulatory information management tools.
Excellent project management and cross-functional collaboration skills.
Strong communication and stakeholder management capabilities.
Analytical thinking, problem-solving ability, and strategic decision-making skills.
High integrity, professional ethics, and ability to work in complex regulatory environments.
Education Requirements
Bachelor’s degree in Pharmacy, Life Sciences, or a related discipline.
A Master’s degree in Regulatory Affairs, Pharmacy, or Life Sciences is preferred.
Experience Requirements
Minimum 10 years of experience in Regulatory Affairs within the pharmaceutical, medical device, or CRO industry.
At least 2 years of experience in team leadership or people management roles.
Experience handling regulatory submissions and approvals in India is essential.
Knowledge or exposure to biologics, specialty medicines, or orphan drugs will be considered an advantage.
Travel Requirements
This role may require occasional domestic and international business travel to support regulatory meetings, global collaborations, and interactions with health authorities.
Why Join Takeda
Takeda offers a global platform for professionals who are passionate about advancing healthcare innovation and regulatory excellence. Employees benefit from working in a purpose-driven organization that values integrity, collaboration, and scientific advancement.
As a certified Global Top Employer, Takeda provides opportunities for career growth, encourages innovation, and supports employees in delivering impactful healthcare solutions that improve patient lives worldwide.
Equal Employment Opportunity
Takeda is committed to building a diverse and inclusive workforce. The company provides equal employment opportunities to all applicants and employees regardless of race, gender, religion, disability, age, sexual orientation, gender identity, or any other legally protected status.
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