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Regulatory Compliance Specialist
1 week ago
Metina PharmConsulting Pvt. Ltd.
We are a reputable pharmaceutical consulting firm operating in the realm of GMP and Global Regulatory Affairs.
About Us
Our organization is headquartered in Mumbai, with subsidiaries in Singapore and Australia, and we are currently expanding our presence in Europe.
We have been providing high-quality and timely consulting services to the pharmaceutical industry in India and internationally.
Company Values
We pride ourselves on having a young and committed team of GMP and regulatory experts.
Job Opportunity
We are seeking a dynamic and driven Regulatory Compliance Specialist who can thrive in our entrepreneurial environment.
The ideal candidate will be responsible for delivering regulatory consulting services, including but not limited to:
- Ownership of assigned regulatory projects, encompassing dossier writing, submissions, approval tracking, query resolution across developed markets (UK, Australia, EU, and US) and emerging markets
- Ensuring regulatory compliance, accuracy, timely completion, version control, and adherence to internal SOPs
- Providing strategic input to management and partners on regulatory projects
- Maintaining knowledge of new developments in regulations across all critical health authorities
Qualifications and Experience
- A minimum of 3-6 years of experience in regulatory affairs, specifically in small molecules
- Familiarity with ICH CTD guidelines and other regulatory requirements from developed markets (US, EU, UK, etc.)