Regulatory Affairs
Regulatory Affairs137
Applications
137
Applications
Ahmedabad
Full-Time
Senior: 11 to 16 years
Posted on Jun 20 2024
Not Accepting Applications
About the Job
Skills
Strong communication skills
Project management skills
Analytical thinking
Problem-solving skills
Ability to work under pressure
Regulatory Affair
Dossier submission
eCTD submission
Company
Pharmazone is fast Growing consulting Firm in GXP services, Regulatory affairs & Pharmacovigilance space. And we are looking forward to add some great assets to the Business Development Team. In case this interests you, would love to connect.
Requirements
- Having total 10 to 15 years of RA experience. Out of which at least 6 years of regulated market such as USA/EU/UK or CA market dossier submission experience, multiple market experience is advantage.
- Having good written and verbal English communication skills
- Having team handling experience
- Should be aware of eCTD submissions
Responsibilities
- Act as a regulatory lead
- Responsible for execution and delivery of all RA projects
- Help and perform dossier drafting, compilation for all markets
- Perform quality check of all the RA team output
- Responsible for all regulatory submission from RA team
- Represent project status to client and to RA HOD.
- Mentor less experienced/new staff members.
Kindly visit our Official Website to know more about us - https://www.pharmazones.com/
About the company
Pharmazone is a leading Consulting company with a strong legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs, Pharmacovigilance, GxP Compliance solutions to clients for improving patients lives through unique Commit-Collaborate-Carry Model. As a Regulatory Specialist, we assist our clients with solutions like Regulatory Inte ...Show More
Pharmazone is a leading Consulting company with a strong legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs, Pharmacovigilance, GxP Compliance solutions to clients for improving patients lives through unique Commit-Collaborate-Carry Model. As a Regulatory Specialist, we assist our clients with solutions like Regulatory Intelligence & Strategy, Medical Writing, Submission & Publishing, Artwork, Labelling, translation, Health Authority interactions, and all post-approval requirements including an end to end Pharmacovigilance services like case management, Aggregate Reports, Signal Detection, MICC, etc. Our objective is to help large, medium & small-size life science companies in efficient execution & compliance of their drug development plans and Post-Approval Requirements for regulated markets and the developing world. Global Regulatory Landscape is dynamic and our compliance services (GXP) play a vital role for clients. Being a trendsetter in GCP Auditing & Consulting, Pharmazone has successfully carried out 2000+ projects for Clinical Monitoring (Bioequivalence, Late Phase), Study Design, Audits, CRO setup & Up-gradation & Programme Management. Our GMP Solutions include Audits, Report Library, Quality Consulting, USFDA/EMA/PICS/WHO accreditation Support, CSV & Engineering Services including Plant Setup & Upgradation. Though Client's trust is our biggest recognition, our hard work-filled journey has brought us various awards like "Best HealthCare Brand" by CMO Asia -ABP News, Top 10 Clinical Research Provider by Silicon India. "Value Creation by Right solutions is Working Mantra at Pharmazone. The expert team at our global locations (INDIA, USA, CANADA and CHINA) have served 300+ Clients to satisfaction and we look forward to serving you! ...Show Less
Industry
Pharmaceutical Manufactur...
Company Size
51-200 Employees
Headquarter
Ahmedabad
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