Job as Regulatory Affairs Specialist at Apothecon Pharma
- About the Company:
- Company Vacancies List:
- Job Description:
- Responsibilities:
- Qualifications:
- About the Department & Responsibilities:
- How to Apply:
Apothecon Pharmaceuticals Pvt. Ltd., a leading player in the pharmaceutical industry dedicated to innovation and excellence. We are excited to announce a career opportunity for a Regulatory Affairs Specialist based in Vadodara, Gujarat, India. This role offers a chance to be part of a dynamic organization committed to making a significant impact on the healthcare landscape.
About the Company:
Apothecon Pharmaceuticals Pvt. Ltd. is a renowned pharmaceutical company known for its commitment to quality and innovation. With a legacy of groundbreaking discoveries, we continue to push the boundaries of science to provide healthcare solutions that make a difference.
Company Vacancies List:
- Position Title: Regulatory Affairs Specialist
- Company Name: Apothecon Pharmaceuticals Pvt. Ltd.
- Location: Vadodara, Gujarat, India
Job Description:
As a Regulatory Affairs Specialist at Apothecon Pharma, you will play a crucial role in ensuring compliance and regulatory success. Here’s a glimpse of what the role entails:
Responsibilities:
- Exposure:
- Preparation and review of ANDA for US Submission for oral solid dosage form (Tablet & Capsule) /Parenteral formulation.
- Responding to the ANDA deficiency.
- Review of CMC section of drug substance for ANDA submission.
- Submission of Post-approval changes (viz. PAS, CBE-0, CBE-30).
- Review of Bioequivalence study protocol and report.
- Submission of Annual report/PADER to FDA.
- Knowledge in eCTD software.
Qualifications:
- B. Pharma/M. Pharma/MSc
- Experience: Minimum 5-6 years.
About the Department & Responsibilities:
Joining the Regulatory Affairs team means stepping into a realm of critical responsibilities. You will be involved in:
- Preparation and review of ANDA submissions.
- Handling deficiencies in ANDA submissions.
- Reviewing the CMC section of drug substances.
- Managing Post-approval changes and Bioequivalence studies.
- Submission of Annual reports and PADER to FDA.
- Proficiency in eCTD software.
How to Apply:
Ready to be part of Apothecon Pharma’s journey? Share your profile with us by emailing anil.patel@apotheconpharma.com
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