Regulatory Affairs Specialist

1 day ago


Hyderabad, Telangana, India PharmSol Group Full time ₹ 4,00,000 - ₹ 8,00,000 per year

Company Description

PharmSol is an integrated pharmaceutical services company providing a full range of pharmaceutical services to meet the needs of generic pharmaceutical companies worldwide. We tailor our solutions to suit the specific needs of our clients, ensuring seamless and timely deliverance. With a focus on EU and US Regulatory Compliance, our services span Development, IPR, Facility Design, Qualifications, Audits, Registrations, Market Access, and Supply Chain. PharmSol's innovative approach in Compliance and Project Management has made us synonymous with high standards in the industry. For more information, visit or contact us at -

Role Description


Preparation of Dossiers in eCTD format.

Response to the Queries received from Regulatory authority / Stake holders.

Review and preparation of Dossier review reports of Dossiers received.


Preparation of Module 1 Documents

Preparation of documentation for filing variations to Regulatory authorities

MA Transfer of the Product approved with Regulatory authorities

Qualifications

  • M. Pharmacy - Pharmaceutics or M Pharmacy - Regulatory Affairs.
  • Effective communication and writing emails.
  • Proficient in handling Reservations
  • Communication with all stake holders to drive the project.
  • Effective Communication skills
  • Ability to multitask and handle a fast-paced work environment
  • Experience in the pharmaceutical industry is a plus
  • High school diploma or equivalent


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