Post: Regulatory Professional I
About the Department
RA CMC & Device Bangalore is an integral part of RA CMC & Device and comprised of over 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.
Job Description
- Timely Submissions: As a Regulatory Professional II, the candidate will be responsible for making timely submissions to Health Authorities worldwide.
- CMC File Management: Establish and maintain the CMC part of the core regulatory file. Further responsibilities include Life Cycle Management.
- Submission Planning: Support submission planning by applying intelligence and developing Regulatory strategy. Create and maintain Regulatory Submission Plan including creation/review documents.
- Regulatory Files: Support submission of Regulatory files, handling Change Requests & Deviations, response to RSI/HA queries worldwide, Annual Reporting, and maintenance of marketing authorization globally.
- NDA, Renewals & Post Approval Changes: Provide support to NDA, Renewals & Post Approval Changes.
- Veeva Vault Experience: Hands-on experience with Veeva Vault (Submission & Registrations).
Candidate Profile
The candidate will play a key role in stakeholder management and will be responsible for ensuring the appropriate use of communication channels to strengthen relationships with stakeholders.
- Experience: 7-8 years within Regulatory affairs with a Graduate/Postgraduate degree in Life-Science/Chemistry/Pharmacy/Medicine/Biotechnology engineering.
- Global & Affiliate Experience: Experience of working both in a Global & Affiliate environment will be preferred.
- Regulatory Processes: Good understanding of end-to-end Regulatory Processes and Life Cycle Management.
- Negotiation Skills: Bold and strong personality with proven negotiation skills and excellent project management skills.
- Communication Skills: Should be able to convince and put forward 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.
- Cultural Sensitivity: High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.
- Communication Skills: Excellent written/spoken communication skills.
Additional Information
- Experience: 5+ years
- Qualification: M.Pharm, B.Pharm, M.Sc, B.Sc
- Location: Bangalore
- Industry Type: Pharma/ Healthcare/ Clinical research
- Functional Area: Reg Affairs & Safety Pharmacovigilance
- End Date: 24th May 2024
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