Regulatory Affairs Associate at Novartis International AG

Job ID: 352024BR
Division: SANDOZ
Job type: Full-time
Employment Type: Temporary
Business Unit: Commercial OPS SIR SZ
Functional Area: Research & Development

Responsibilites
This role will be responsible to:

• Contribute and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.
• Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.
• Set registration plan, to perform product registration in accordance with registration and launch plan, & maintain product license with local regulation and global compliance strategy
• Review new projects and set development plan (timeline etc.) in collaboration with Global DRA and related CPO functions (Marketing, HE&P and CD&MA etc.)
• Achieve the best product registration with commercially attractive labelling in accordance with registration plan
• Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.)
• Foster and maintain good relations with internal and external stakeholders
• Reporting of technical complaints / adverse events / special case
• Successful candidates will have the opportunity for career growth and development through diverse learning platforms as well as mentoring and coaching required to succeed in current role and also be set up for success in future aspirations within the organization.

Commitment to Diversity & Inclusion:

• Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Job Requirements

• Bachelor's Degree in Pharmacy
• Relevant experience in the Pharmaceutical Industry.