Partner - Regulatory Affairs
Partner - Regulatory Affairs
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Job Description
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 and Clinical Trials (NDCT) Rules Indian GCP and ICHGCP guidelines. The candidate will play a pivotal role in coordinating with global and local stakeholders to ensure timely submissions approvals and postapproval compliance for biologicals new 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 highquality submissions in compliance with NDCT Rules.
Coordinate with crossfunctional teams and liaise with health authorities (e.g. CDSCO DCGI) for successful outcomes.
Lifecycle Management
Manage postapproval 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.
CrossFunctional 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 Bachelors/Masters 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.
Indepth knowledge of NDCT Rules GSR notifications Indian GCP ICHGCP 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 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 lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Employment Type
Full-Time
