Partner - Regulatory Affairs

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

Partner Regulatory Affairs (SE 6)

Job Location: Mumbai or Delhi

The Position

We are seeking a highly motivated and experienced Partner – Regulatory Affairs who will be responsible for leading and executing regulatory strategies and submissions in alignment with the New Drugs and Clinical Trials (NDCT) Rules, Indian GCP, and ICH-GCP guidelines. The candidate will play a pivotal role in coordinating with global and local stakeholders to ensure timely submissions, approvals, and post-approval compliance for biologicals, new drugs, and subsequent new drug products and Global clinical trials.

Your Opportunity

In this role, you will be involved in the following :

Regulatory Submissions & Approvals

• Lead strategic discussions, preparation, review, and submission of regulatory dossiers for MA applications while ensuring timely, high-quality submissions in compliance with NDCT Rules.
• Coordinate with cross-functional teams and liaise with health authorities (e.g., CDSCO, DCGI) for successful outcomes
  
  

Lifecycle Management

• Manage post-approval lifecycle activities, prepare and submit applications for registration and import licenses, and ensure compliance and timely renewals of regulatory commitments
  
  

Clinical Trial Submissions

• Lead meetings and manage submissions for Global Clinical Trials (GCTs) as per relevant guidelines, while collaborating with clinical and global teams to ensure regulatory compliance in India
  
  

Compliance & Inspection Readiness

• Ensure regulatory compliance and maintain inspection readiness for products intended for market release, supporting local audits and inspections
  
  

Labeling & Promotional Material Review

• Manage and review local product labeling and promotional materials to ensure compliance with global/local regulatory and ethical guidelines
  
  

Regulatory Intelligence & Strategy

• Continuously monitor and interpret regulatory changes and competitor activities, sharing timely updates and insights with internal stakeholders
  
  

Systems, Documentation & Process Management

• Ensure accurate documentation and management of regulatory activities and data, while maintaining and updating local Regulatory Affairs SOPs in adherence to quality standards
  
  

Cross-Functional Support

• Provide regulatory support to local market access, quality, medical affairs, and commercial teams while working collaboratively on assigned tasks
  
  

Who you are

• You are someone who has a relevant Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or a related field
• From an experience standpoint having more than 9+ years’ experience in dossier preparation (CTD/eCTD), handling health authority queries, and lifecycle management
• In-depth knowledge of NDCT Rules, GSR notifications, Indian GCP, ICH-GCP, and CDSCO regulatory pathways
• Excellent communication, collaboration, and project management skills
• Strong attention to detail and ability to manage multiple priorities in a dynamic environment
  
  

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.