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Regulatory Affairs Manager

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Qualifications:- Bachelor's or Master's degree in Science (B. Sc / M. Sc)- 8 to 10 years of experience in Bulk Drugs / API regulatory affairs.

About the job

We are excited to announce immediate openings for the position of “Regulatory Affairs Manager” with one of our esteemed clients located in Hosur.

About the Position:

Title: Regulatory Affairs Manager

Qualifications: B. Sc / M. Sc

Experience: 8 - 10 years in Bulk Drugs / API

Location: Hosur

Key Responsibilities:

  • Prepare and review Drug Master Files and Common Technical Documents for various drug substances.
  • Compile and submit Technical Packages and Product Dossiers.
  • Draft Declarations of Access, Letters of Access, Letters of Commitment, and Submission Letters.
  • Address deficiencies raised by regulatory agencies and customers.
  • Prepare and submit Quality Questionnaires and related documentation from customers.
  • Collaborate with Quality Control, Quality Assurance, Stores, Production, and R&D regarding regulatory requirements.
  • Provide marketing support as needed.
  • Prepare and submit documents for Drug Licenses, Written Confirmations, NOCs, FSSAI Licenses, Free Sale Certificates, and GMP Certificates.
  • Undertake any other tasks assigned by the department head.
  • Enhance, periodically review, and update current SOPs and work systems.
  • Ensure that sourcing materials, manufacturing, and testing are aligned with the dossier accepted by the relevant regulatory agency.
  • Monitor the qualification of new or modified areas/equipment and ensure their requalification.
  • Review technical and quality agreements.

About Aarna HR Solutions Pvt. Ltd.

Welcome to Aarna HR Solutions! We are a leading Human Resource Recruitment Company dedicated to providing exceptional recruitment services to various IT, ITES, and non-IT companies across India. At Aarna, we are committed to attracting and hiring the brightest talent in the industry, fostering a culture of pride in performance, teamwork, and a relentless pursuit of excellence.

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