Metina PharmConsulting Pvt. Ltd.
Website:
metinapharmconsulting.com
Job details:
Position – Consultant
Company Information
We are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. We have been providing high quality & timely consulting service to the Biopharmaceutical and Pharmaceutical Industry in India and internationally. We have a young and committed team of GMP and Regulatory Experts.
We are inviting applications for the role of Regulatory Consultant and are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm.
Role & Responsibilities
The person will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following:
- Ownership for assigned regulatory projects including regulatory strategy, dossier writing, submissions, approval tracking, query resolution (EU, UK, AUS)
- Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs
- Providing strategic input to the Management and Partners on regulatory projects
- Keep abreast of new developments in regulations across all critical health authorities
Experience & Qualifications
- Total: 16-20 years of Core Regulatory experience in generics/ formulations / small molecules mandatory.
- Must have 2-3 years hands-on experience in authoring CTD Module 3 sections independently for EU/US/UK/ Canada regulatory submissions
- Proven end-to-end experience owning regulatory submissions and approvals, including responding to regulatory deficiencies
- Mastery of regulatory guidelines and ability to stay abreast of regulations (ICH, WHO, USFDA, EU, AUS, UK)
- Academic Qualifications: B.Pharm, M.Pharm, M.Tech, M.Sc. in Microbiology, Biotechnology or Life Sciences background
- Demonstrated strong English communication skills, combined with basic computer skills
- Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to details
Mail us your CV at info@metinapharmconsulting.com
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