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79 ClinChoice Jobs
Specialist-Regulatory Affairs CMC
ClinChoice
posted 13hr ago
Job Role Insights
Flexible timing
Job Description
Primary Responsibilities:
- Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval.
- Responsible for writing CMC modules 2 & 3.
- Exposure to EU & CIS region in Regulatory filings
- Manage and coordinate product life cycle management.
- Ensure regulatory compliance with local regulatory requirements.
- Foster and maintain professional relationships with the health authorities.
- Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary.
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
- Promote regulatory intelligence in both local and regional initiatives.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
- Responsible for reviewing CMC modules.
- Execution of regulatory strategies (local and regional) in line with business plan.
- Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
- Ensure to adherence to timelines and quality set parameters.
- Review of Formulation, generation of ingredient list and Claims as per set standards.
Qualification
- Minimum B.S. Chemistry, Pharmacy or related scientific field
- Experience in CMC regulatory affairs for pharmaceutical products.
- Experience in Module 3, Module 2.3 and relevant Module 1 e-CTD documentation
Employment Type: Full Time, Permanent
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What people at ClinChoice are saying
Regulatory Affairs salary at ClinChoice
reported by
1
employee
with 4
years exp.
₹5.4
L/yr - ₹6.9
L/yr
At
par with the average Regulatory Affairs Salary in India
View more details
What ClinChoice employees are saying about work life
based on 90 employees
Flexible timing
Monday to Friday
No travel
Day Shift
ClinChoice Benefits
View more benefits
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