Regulatory Affairs Expert with US Filing Experience

1 week ago


Hyderabad, Telangana, India Eugia Pharma Specialities Ltd Full time

About the Role

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We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Eugia Pharma Specialities Ltd. This is a fantastic opportunity to work in a dynamic environment and contribute to the success of our organization.

Key Responsibilities

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The successful candidate will be responsible for planning, reviewing and submitting assignments for ANDA and NDA projects. They will also be expected to draft high-quality responses to FDA deficiencies with excellent drafting skills and regulatory standards.

Other key responsibilities include evaluating and interpreting post-approval changes, submitting supplements such as CBE, CBE-30 and Prior Approval Supplements (PAS), and reviewing and authorizing regulatory change controls.

Requirements

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To be considered for this role, applicants must have excellent knowledge of eCTD, Module 2 and 3. They should also be able to formulate a US regulatory filing strategy for new projects.

A minimum of 3-8 years of experience in regulatory affairs is required, along with a Master's degree in Pharmacy (M Pharm). The ideal candidate will be located in Hyderabad and have a strong understanding of regulatory requirements in the pharmaceutical industry.

What We Offer

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Eugia Pharma Specialities Ltd offers a competitive salary of ₹25 lakhs - ₹35 lakhs per annum, depending on experience. In addition to a lucrative salary, we offer a range of benefits including health insurance, retirement plans and opportunities for career growth and development.

We are an equal opportunities employer and welcome applications from qualified candidates who are passionate about regulatory affairs and committed to delivering high-quality results.



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