At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

Thats what makes us Roche.

The Position

Location: Delhi India

At Roche Diagnostics India we are looking for a dedicated and experienced Regulatory Affairs professional to join our this role you will report to the Head of Regulatory Affairs and play a critical part in implementing regulatory strategies and ensuring compliance for submissions and licenses across India and neighboring markets (Sri Lanka Bangladesh are preferred but not mandatory).

Your contributions will support timely market access and uphold regulatory excellence for Roche Diagnostics diverse and innovative portfolio.

Your Opportunity

In this role you will operate with ownership and accountability in managing regulatory documents coordinating with global stakeholders and ensuring compliance with local regulations. Youll be a vital link between Roche and regulatory authorities driving timely submissions and approvals while upholding the highest standards of ethics and accuracy.

Day-to-Day Responsibilities

• Regulatory Submissions & Approvals
  Prepare and manage applications for import licenses registrations demergers and retention ensuring timely submissions to health authorities in India and neighboring markets.

• Stakeholder Coordination
  Liaise with the global regulatory team and internal functions to gather required documentation and support cross-functional regulatory needs.

• Compliance & Promotional Review
  Review marketing and promotional materials to ensure alignment with local guidelines and regulations.

• Regulatory Intelligence
  Monitor changes in local regulations (India & NM) and support the team in adapting accordingly.

• Incident Reporting & Tender Support
  Assist in adverse incident reporting and support submissions for tenders and National Institute of Biologicals (NIB) as required.

• Authority Liaison
  Regularly coordinate and follow up with regulatory bodies to facilitate prompt approvals.
  Documentation & SOPs
  Respect and follow internal SOPs and documentation systems in line with regulatory requirements.

• Knowledge Contribution
  Share regulatory knowledge support training initiatives and promote a collaborative team culture.

Who You Are

You are a self-driven regulatory affairs professional who thrives in a fast-paced environment. You bring both technical expertise and a collaborative mindset to the table always aiming for excellence in execution.

Must-Have Qualifications:

• 47 years of relevant experience in Regulatory Affairs preferably in the Diagnostics (IVD) or Medical Device industry.

• Postgraduate in Life Sciences M. Pharm or equivalent.

• Strong understanding of Indian regulatory frameworks; knowledge of Bureau of Indian Standards (BIS) is an added advantage.

• Experience working with regulatory bodies in India; exposure to Sri Lanka and Bangladesh markets is a plus.

• Proven ability to work independently and within cross-functional teams.
  

Other Key Skills:

• Strong written and verbal communication

• Analytical thinking and problem-solving abilities

• Meticulous attention to detail

• Adaptability and a continuous improvement mindset

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.