Clinical Regulatory Affairs Manager – Takeda

Are you an experienced professional looking to take the next step as a Clinical Regulatory Affairs Manager? Takeda Pharmaceuticals, a patient-focused, values-based, global biopharmaceutical leader, is currently seeking a qualified candidate to fill this critical opening at its Gurgaon office. This is an incredible opportunity to advance your career on a globally diverse team that values innovation, equity, and inclusion.

Role Overview

Takeda is a world-renowned biopharmaceutical company with a rich 240-year history of delivering life-transforming treatments to patients worldwide. In this full-time, senior-level role, you will fit into the Global Regulatory Affairs (GRA) division. The GRA team plays a strategic role across all stages of global product development. Minimal travel is expected for this regular employee position, and you will work from the corporate hub in Gurgaon, India. You can search Gurgaon Jobs or explore our full platform to browse Healthcare Jobs to see how this role compares to other active listings in the region.

Key Responsibilities

1. Submission Leadership: Manage and lead the preparation, submission, and tracking of CTAs, substantial/non-substantial amendments, and notifications to the Central Drugs Standard Control Organisation. You can find comprehensive regulatory compliance resources on the official CDSCO Website.

2. Health Authority Interactions: Ensure timely, complete, and compliant responses to HA questions and deficiency letters to prevent avoidable approval delays. Drive readiness for HA meetings, including SEC briefing preparations.

3. Strategic Guidance: Provide clear regulatory consultation and guidance to cross-functional study teams on Indian clinical trial requirements, translating complex guidelines into actionable risk-mitigation plans.

4. Compliance Monitoring: Oversee regulatory compliance monitoring during study conduct, ensuring adherence to regulatory commitments and inspection readiness.

5. Systems Management: Utilize cutting-edge regulatory information management tools like Veeva RIM to ensure precise tracking and documentation across all clinical submissions.

Also Check: Product Manager – Roche

Requirements

1. Education: A Bachelor’s degree in Pharmacy, Life Sciences, Medicine, or a related field is required (an advanced degree is highly preferred).

2. Experience: Minimum of 5 years of experience in the pharmaceutical industry or a Contract Research Organization (CRO) specifically managing regulatory affairs for clinical trials in India.

3. Technical Knowledge: Demonstrated hands-on experience with CTA submissions and amendments, alongside a robust working knowledge of Indian clinical trial regulations and HA/SEC expectations.

4. Software Skills: Strong documentation discipline and direct expertise in Regulatory Affairs tools, particularly Veeva systems.

5. Soft Skills: Outstanding written and verbal communication skills, exceptional planning and prioritization capabilities, and proven stakeholder management abilities within a matrixed global corporate environment.