Regulatory Affairs Specialist
6 days ago
Job Summary
Aurolab seeks a highly skilled Regulatory Affairs Specialist to lead our product compliance efforts. As a key member of our team, you will be responsible for ensuring our products meet regulatory standards and customer expectations.
About the Role
The ideal candidate will have a deep understanding of USFDA and MHRA regulations, as well as excellent organizational skills and the ability to work collaboratively across departments.
Key Responsibilities
- Prepare, review, and submit regulatory documents for USFDA and MHRA approval, including New Drug Applications (NDA) and Marketing Authorization Applications (MAA)
- Ensure all submissions are accurate, complete, and in compliance with regulatory requirements
- Manage timelines and tracking of regulatory submissions and approvals
- Develop and implement regulatory strategies to ensure timely ANDA submissions and approvals
- Stay up-to-date with regulatory changes and updates from USFDA and MHRA
Requirements
- Bachelor's degree in Pharmacy or related field
- Minimum 7-10 years of experience in pharmaceutical or biotechnology industry
- In-depth knowledge of USFDA and MHRA regulations and guidelines
What We Offer
We offer a competitive salary of $120,000 per year, commensurate with experience, plus benefits and opportunities for professional growth.
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