Apothecon Pharma Hiring Regulatory Affairs Openings in Nashik and Navi Mumbai

apothecon pharma Hiring Regulatory Affairs Professionals

At Apothecon Pharma Pvt Ltd, we’re on a mission to redefine pharmaceutical innovation. Founded on principles of excellence and commitment, we strive to create groundbreaking medical solutions that positively impact lives globally. As a leader in the industry, we prioritize talent and expertise, fostering a culture of collaboration and innovation.

Company Overview

apothecon pharma Pvt Ltd is a pioneering pharmaceutical company dedicated to research, development, and manufacturing of cutting-edge medical products. Our commitment to excellence drives us to explore new frontiers in medical science, with a focus on regulatory compliance and quality assurance. Founded by visionary leaders, our company culture thrives on integrity, creativity, and a relentless pursuit of excellence.

Current Vacancies

• Regulatory Affairs – Formulation
  • Position: Executive, Senior Executive
  • Education: B Pharma, M Pharma, MSc
  • Experience: 4-9 years in RA [US /Europe Markets]
• Regulatory Affairs – API
  • Position: AM, DM
  • Education: B Pharma, M Pharma, MSc
  • Experience: 7-15 years in RA [US/Europe Markets]

Job Description

Regulatory Affairs – Formulation

Role and Responsibilities:

• Preparation and review of ANDA for US Submission for oral solid dosage form (Tablet & Capsule)/Parenteral formulation.
• Responding to ANDA deficiencies.
• Review of CMC section of drug substance for ANDA submission.
• Submission of Post-approval changes (PAS, CBE-0, CBE-30).
• Review of Bioequivalence study protocol and report.
• Submission of Annual report/PADER to FDA.
• Knowledge in eCTD software.

Regulatory Affairs – API

Role and Responsibilities:

• Submission of DMF/ASMF/CEP for API in eCTD format for US/Europe and other regulatory agencies.
• Compilation, review, and filing of DMF.
• Review of analytical documents required for DMF/ASMF.
• Evaluation of changes for their implication in the filed DMF/ASMF, CEP.
• Experience in submission of Open and closed part for the ASMF in reference to various EU procedures (National, DCP, MRP, etc.).

How to Apply

Interested candidates are encouraged to share their profiles at anil.patel@apotheconpharma.com. Join us in our mission to revolutionize pharmaceuticals and make a positive impact on global healthcare.