- Full Time
- Gurgaon, Haryana

Website Takeda Pharmaceutical
Job Title: Regulatory Affairs Manager
Location: Gurgaon, Haryana
Industry: Pharmaceutical/Healthcare/Clinical Research
Join Takeda in Delivering Life-Changing Medicines!
About Takeda Pharmaceutical
At Takeda Pharmaceutical Company Limited, more than 30,000 employees across 70 countries are committed to improving the quality of life for patients worldwide. We are a global leader in research and development, focusing on oncology, gastroenterology, neuroscience, and vaccines for critical infectious diseases. Our novel products, particularly in oncology and gastroenterology, along with our expanding presence in emerging markets, drive our growth.
Role Overview
We are looking for a Regulatory Affairs Manager to lead and develop regulatory strategies for new and existing products across India, Sri Lanka, Bangladesh, and Nepal. In this role, you will ensure that all regulatory activities comply with local and global regulations and contribute to our goal of translating cutting-edge science into life-changing medicines.
Key Responsibilities
1. Regulatory Planning & Strategy
- Develop and execute regulatory plans for product submissions in line with local regulations and corporate strategies.
- Collaborate with cross-functional teams to ensure timely preparation of regulatory dossiers.
- Ensure alignment of regulatory plans with product teams and business objectives.
2. Submissions & Approvals
- Prepare and submit high-quality regulatory dossiers within established timelines.
- Liaise with health authorities to secure timely product approvals.
- Manage post-approval commitments and maintain compliance with packaging and labeling requirements.
3. Regulatory Compliance
- Ensure that all marketed products remain compliant with local and corporate regulatory requirements.
- Conduct self-audits to identify compliance risks and implement corrective actions.
- Maintain and update standard operating procedures (SOPs) as per global and local regulatory requirements.
4. Regulatory Influence & External Relations
- Build and maintain relationships with key regulatory officials to foster a positive regulatory environment.
- Stay informed about regulatory changes and communicate updates to relevant stakeholders.
- Support the development and implementation of external regulatory influence strategies.
Candidate Profile
Qualifications:
- Bachelor’s in Pharmacy, Master’s in Chemistry, Life Sciences, Biotechnology, Biomedical Engineering, or equivalent degree.
- 8-10 years of experience in the pharmaceutical, medical device, or clinical research industry.
Skills and Competencies:
- In-depth knowledge of local regulatory requirements for pharmaceutical products.
- Strong project and stakeholder management skills.
- Excellent communication, both verbal and written.
- Ability to develop strong relationships with health authorities and regulatory agencies.
- Business partner mindset with a focus on accelerating product registration and maintaining compliance.
Additional Information
- Experience: 8-10 years
- Location: Gurgaon, Haryana
- Functional Area: Research & Development
- Application Deadline: 30th October 2024
Join Takeda and contribute to improving patient outcomes through innovative medicines! Apply today to be a part of a leading global organization dedicated to transforming the future of healthcare.
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