Manager - Regulatory Affairs

The Position

This position is based in Delhi

About the role

Roche Diagnostics India is looking for a committed Regulatory Manager with a structured and growth mindset.' We offer a challenging and varied job in an active and flexible working environment, where you will have responsibility for handling regulatory tasks and outcomes.  You will also become part of an innovative and extremely dynamic organization.

Role purpose

The role performs the coordination and preparation of document packages for regulatory submissions in India for new and registered products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company as well as internal audits and inspections. Contribution to Regulatory Policy shaping.

Roles & Responsibilities

• You shall plan and execute strategies to ensure timely execution of change management, acquisition, demerger, registration and import license approvals.
• You will Independently prepare regulatory documents e.g Import License application, retention application, review regulatory applications & submissions pertaining to Roche Diagnostics with full responsibility and accountability.
• Act as a single point of contact for specified business area(s) and co-ordinate with global regulatory team, local Business Areas & other functions, required for regulatory submissions at India & NM FDA.
• Lead the Product Launch discussion with Global and Local stakeholders.
• Review Marketing and Promotional Materials as per local guidelines and compliance.
• Knowledge about Bureau of Indian Standards
• Keep track of regulatory requirement in India & NM and prepare impact assessment for management review.
• Assist in adverse incident reporting to health authorities.
• Responsible for close coordination & regular follow-up with the Regulatory Authority for timely obtaining of approvals.
• Work closely with the Regulatory Team, train the team and foster the teamworkculture.
• Ensure the organization’s Regulatory Affairs activities are conducted accurately, ethicallyand according to relevant regulations, laws andstandards
• Respecting & following applicable SoPs / system implemented within the departmentand organization.

Experience

More than 7 years RA experience in a reputed organization (preferably in Diagnostics (IVD) or Medical Device Industry)

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

For more than 60 years, Roche has been committed to making a difference to the lives of people in India. Roche Diagnostics India is the market leader in In-Vitro-Diagnostics, providing diagnostic testing for early detection, evaluation and monitoring of disease. On the product side, the organisation provides a wide range of diagnostic products for customers around distinct disease areas namely diabetes, virology, blood screening, women's health, microbiology, oncology and genomics.

Roche is an Equal Opportunity Employer.