Job Description
200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.
Your responsibilities:
Your responsibilities include, but are not limited to:
- Independently handle regulatory compliance activities, including entering product specific attributes as provided by program team representative into Regulatory Information Management System (RIM) (e.g. DRAGON).
- Timely preparation of all DRAGON information updates and compliance reconciliation reports in accordance with established procedures and related timelines.
- Provide support as needed for Routine Health Authority (HA) submissions including Annual Reports, New Protocol Submissions, Protocol Amendment, Renewal, Production Transfer (PT) Submissions (non-EU countries), New Product Planning (NPP) (non EU countries) etc. and as applicable act as main liaison with RA Operations to ensure accurate and timely submissions to HAs
- Independently work for xEVMPD submissions to ensure quality and compliance of the data submitted to EMA
- Support the GPRD/GPRMs by Timely delivery of Safety Labeling change submissions/ HA submissions/ completion of Module #1 in eCTD/ completion of Briefing Books for regulatory HA meetings/ delivery of IND/IMPD (CTAs) and NDA/MAA/CTD for HA submissions/ delivery of Regulatory Intelligence and other regulatory support information
- Independently plan and handle timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufacturing site transfers & new registration submissions in Most of the World (MoW)/Latin America & Canada & Region Europe (non EU countries) and Greater China regions (as per requirements).
- Independently work for procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA’s and other regulatory documents as per the need) to achieve marketing authorization and life cycle maintenance in collaboration with existing internal and external stakeholders
- Independently handle the activities associated with external service providers.Maintenance of up-to-date country requirement lists and plans covering activities in scope through conducting need-based surveys & interaction with COs.Independently handle interaction & collaboration with RA colleagues in Country Organizations (COs) for regulatory maintenance activities. Provides support for internal/external inspections
Minimum Requirements
What you’ll bring to the role:
- Bachelor’s Degree preferred with Minimum of 3 years of pharmaceutical experience with a minimum of 1-2 years of regulatory experience preferred
- Prior publishing/Regulatory Operations experience desired
- Good communication and negotiation skills
- Proactive personality and Ability to build effective relationships across teams/projects
- Fast and flexible, focused on timely delivery and stretch targets
- Ability to plan and prioritize workload for others
- Ability to work in a matrix environment across sites
Source : https://www.linkedin.com/jobs/view/2006417949/
