Company Overview
With over 30,000 employees across 70+ countries, Takeda Pharmaceutical Company is dedicated to improving patient quality of life. We are a research and development-driven organization focused on translating scientific innovations into life-changing medicines. Our primary therapeutic areas include oncology, gastroenterology, neuroscience, and infectious disease vaccines, with an emphasis on novel products and emerging markets.
Position: Regulatory Affairs Manager
Location: Gurgaon, Haryana
Industry Type: Pharma/Healthcare/Clinical Research
Experience Required: 8-10 years
Qualifications: B.Pharm, M.Sc, B.Sc
Application Deadline: 30th October 2024
Job Description
Objectives / Purpose
The Regulatory Affairs Manager will lead and develop regulatory strategies for new and existing products within Takeda’s portfolio. You will oversee local regulatory activities, ensuring compliance with applicable regulations and driving the successful registration of new products and indications in India and neighboring countries (Sri Lanka, Bangladesh, Nepal).
Key Responsibilities
- Regulatory Planning
- Develop and recommend regulatory strategies for submissions, aligning with country regulations and internal business plans.
- Coordinate processes with cross-functional teams to ensure timely documentation for dossier preparation.
- Submissions and Approvals
- Prepare high-quality regulatory dossiers and submit them within planned timelines.
- Achieve Health Authority approvals, maintain product licenses, and ensure compliance with local and corporate regulatory requirements.
- Regulatory Compliance
- Maintain compliance for all marketed products through regular audits and corrective actions as needed.
- Develop and implement standard operating procedures (SOPs) as per global regulatory policies.
- Regulatory Influence
- Establish relationships with key regulatory officials to foster a positive regulatory environment.
- Stay updated on regulatory changes and their implications for business operations.
Candidate Profile
- Education: Bachelor’s in Pharmacy or Master’s in Chemistry, Sciences, Biotechnology, Biomedical Engineering, or Microbiology (or equivalent).
- Experience: 8-10 years in the pharmaceutical, medical device, or CRO industry.
- Skills:
- In-depth knowledge of local product registration regulations and corporate policies.
- Strong understanding of biological and orphan drugs.
- Excellent communication, project management, and stakeholder management skills.
- Ability to build effective relationships with Health Authorities and internal teams.
- Business partner mindset with a focus on problem-solving and creative thinking.
Additional Information
- Strong documentation and cross-functional collaboration skills are essential.
- A commitment to integrity, fairness, and perseverance is crucial for success in this role.
If you are ready to make an impact in the pharmaceutical industry and meet the qualifications listed above, we encourage you to apply for the Regulatory Affairs Manager position at Takeda.
To apply, please submit your resume and cover letter by 30th October 2024.