Executive Regulatory Affairs and Packaging Development
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Mumbai IndiaJob Description:
Compilation of documents for Registration of Drugs
Liaise with regional team for supporting documents and dossiers for product registration and for tenders
Provide inputs of regulatory affairs and ensure HA submissions for PMS and Phase IV studies: Quarterly and six-monthly study reports for PMS studies clinical reports stability protocols and non-clinical study reports
Coordination with Regulatory Consultants for the effective submission of application at DCGI
Archival of dossiers Approvals and DCGI submission copies
Providing support in Life Cycle management of registered products
Managing trackers and supporting tenders by providing various documents from regulatory perspective.
Please note: Candidate is already identified for this role.
Required Skills:
Preferred Skills:
Analytical Reasoning Business Behavior Business Writing Collaborating Communication Confidentiality Data Reporting Data Savvy Detail-Oriented Execution Focus Legal Support Medicines and Device Development and Regulation Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments
Key Skills
- Athletics
- Corporate Banking
- IT Management
- Facilities
- IT Support
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
