Require Regulatory Professional at Novo Nordisk
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Regulatory Professional II
About the department
RA CMC & Device Bangalore is an integral part of RA CMC & Device and comprised of +60 experienced professionals associated with key regulatory processes covering Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR) and submission of regulatory files, product registrations and life cycle management of our products. We are responsible for driving the RA CMC strategies and submission activities related to various biotech and rare disease, Diabetes & Obesity products and medical devices.
Our organization is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking “out of the box”, setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients we serve. We continuously strive for scientific and operational excellence.
About the department
RA CMC & Device Bangalore is an integral part of RA CMC & Device and comprised of +60 experienced professionals associated with key regulatory processes covering Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR) and submission of regulatory files, product registrations and life cycle management of our products. We are responsible for driving the RA CMC strategies and submission activities related to various biotech and rare disease, Diabetes & Obesity products and medical devices.
Our organization is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking “out of the box”, setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients we serve. We continuously strive for scientific and operational excellence.
Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. Looking forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people.
Job Description
As Regulatory Professional II, the candidate will be responsible for making the timely submissions to the Health Authorities worldwide. The candidate is expected to establish and maintain the CMC part of the core regulatory file.
Further responsibilities include Life Cycle Management.
• Support submission planning : Apply intelligence and develop Regulatory strategy. Create and maintain Regulatory Submission Plan including creation/review documents.
• Support submission of Regulatory files, Handling Change Requests & Deviations, response to RSI/ HA query worldwide, Annual Reporting and maintenance of marketing authorization globally.
• Support to NDA, Renewals & Post Approval Changes.
• Hands on experience with Veeva Vault (Submission & Registrations).
The candidate will be playing a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders.
Candidate Profile
• 7-8 years of experience within Regulatory affairs with Graduate /
• Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine/ Biotechnology engineering.
• Experience of working both in Global & Affiliate environment will be preferred.
• Good understanding of end-to-end Regulatory Processes and Life Cycle Management.
• Bold and strong personality with proven negotiation skills and excellent project management skills.
• Should be able to convince and put forward the facts confidently.
• Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results.
High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.
• Excellent written/spoken communication skills.
Additional Information
Experience : 7-8 years
Qualification : M.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Reg Affairs & Safety Pharmacovigilance
End Date : 25th May 2024
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