Johnson & Johnson, a global leader in healthcare innovation, continues to pioneer advanced medical solutions that improve and save lives worldwide. The company is now hiring an Assistant Manager – Regulatory Affairs at its Gurgaon location, offering an exciting opportunity for experienced professionals in regulatory compliance within the pharmaceutical and medical device sector.
This role invites candidates with 5 to 8 years of relevant experience to be part of a dynamic team that ensures adherence to regulatory standards, manages product lifecycle compliance, and supports business growth through strategic regulatory planning.
🔍 About Johnson & Johnson India
Johnson & Johnson’s India operations align with the company’s global mission to deliver smarter, less invasive, and personalized healthcare breakthroughs. Leveraging expertise in innovative medicine and MedTech, Johnson & Johnson focuses on pioneering solutions that tackle complex diseases and improve patient outcomes.
Their regulatory affairs team plays a critical role in navigating the evolving legal landscape, ensuring that products meet all regulatory requirements and can reach patients safely and efficiently.
📋 Key Responsibilities of the Role
- Regulatory Compliance: Ensure all company products comply with the Medical Device Rule 2017, Drugs and Cosmetics Act, and other applicable Indian regulations.
- Regulatory Submissions: Prepare, review, and submit all regulatory filings related to new product registrations, re-registrations, manufacturer transfers, and post-approval changes.
- Lifecycle Management: Manage product registrations throughout their lifecycle, handling change notifications, addressing regulatory queries, and updating compliance requirements timely.
- Regulatory Strategy: Collaborate with internal stakeholders—including R&D, quality, and business teams—to formulate and implement regulatory strategies that mitigate risks and facilitate smooth product launches.
- Documentation & Reporting: Draft essential regulatory documents such as cover letters and maintain databases (e.g., MDRIM tool) to ensure all filings are accurate and timely.
- Quality Compliance: Address quality-related issues using tools like the ETS system, oversee corrective actions, and ensure all regulatory assessments meet deadlines.
- Stakeholder Coordination: Work cross-functionally to ensure comprehensive compliance across departments and provide regulatory guidance.
- Training & SOPs: Complete mandatory training modules and adhere strictly to SOPs and regulatory guidelines.
🎓 Required Qualifications & Skills
- Strong knowledge of Indian regulatory frameworks, particularly the Medical Device Rule 2017, Drugs and Cosmetics Act, and ISO 13485 Quality Management System (QMS) standards.
- Familiarity with international regulatory requirements such as US FDA and EU MDR for medical devices is highly advantageous.
- Proficiency in regulatory databases and software tools relevant to compliance management.
- Excellent communication, documentation, and project management abilities.
- Ability to interpret complex regulatory guidelines and translate them into actionable compliance strategies.
- Minimum 5-8 years of relevant experience in regulatory affairs within the pharmaceutical or medical device industry.
- Strong problem-solving skills and attention to detail.
🌟 Why Join Johnson & Johnson?
Working at Johnson & Johnson India means being part of a company dedicated to transforming healthcare on a global scale. Some benefits of joining include:
- Global Impact: Contribute to healthcare innovations that affect millions of lives worldwide.
- Hybrid Work Model: Enjoy flexible work arrangements supporting a healthy work-life balance.
- Career Growth: Access numerous opportunities for professional development within a multinational corporation.
- Inclusive Culture: Thrive in a diverse, collaborative, and supportive workplace that values every employee.
- Competitive Salary: Attractive remuneration package ranging from ₹12 to 20 LPA, reflecting your skills and experience.
💼 Work Environment & Growth Opportunities
Johnson & Johnson invests heavily in employee growth by offering robust training programs, mentorship, and exposure to cutting-edge technologies. As an Assistant Manager in Regulatory Affairs, you will have the chance to:
- Lead critical compliance initiatives affecting product registration and market access.
- Collaborate with global teams to gain international regulatory insights.
- Participate in strategic planning that directly influences business success.
- Work in a culture that fosters innovation, responsibility, and continuous learning.
🔑 How to Prepare for This Role
To succeed as an Assistant Manager – Regulatory Affairs at Johnson & Johnson:
- Stay updated with the latest Indian and international medical device regulations.
- Build expertise in regulatory submission preparation and product lifecycle management.
- Develop strong project management and cross-functional collaboration skills.
- Highlight your problem-solving skills and ability to handle compliance challenges effectively.
- Prepare detailed examples from your experience related to regulatory compliance and strategic planning.
🔍 Final Thoughts
Johnson & Johnson’s urgent hiring for an Assistant Manager – Regulatory Affairs opens a door to an enriching career in one of the world’s most respected healthcare companies. If you have the right experience and skills, this is your chance to contribute meaningfully to life-saving healthcare products and develop your career in a globally recognized environment.
Embrace the opportunity to be part of a company that not only innovates but also cares deeply about regulatory excellence and patient safety.
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