Executive - Regulatory Affairs 65e85904fb27c01f25873613

Mega Lifesciences; Thane; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Mega Lifesciences is seeking an Executive - Regulatory Affairs in India to manage international regulatory activities and ensure compliance across markets.

You will review technical documents, prepare dossiers for submissions, liaise with regulatory authorities and stakeholders, and generate progress reports to track timelines and outcomes.

Qualifications

• Graduate with B.Pharm or M.Pharm degree.
• 4 years+ experience in International Regulatory Affairs, Quality Assurance and/or Control.

Responsibilities

• Reviewing technical documents.
• Compilation and submission of dossiers in the countries.
• Communication with key stakeholders.
• Updating the progress status & generating reports.

Skills

Regulatory guidelines

Dosage forms understanding

Documentation management

MS Office

Education

B. Pharm / M. Pharm

Tools

MS Office

Job description

Job Summary

As an Executive - Regulatory Affairs, your key tasks are as below:

• Reviewing technical documents.
• Compilation and submission of dossiers in the countries.
• Communication with key stakeholders.
• Updating the progress status & generating reports.

Qualifications & Experience

• Graduate: B. Pharm / M. Pharm
• Minimum 4 years of experience in International Regulatory Affairs, Quality assurance and/or control.

Skills & Knowledge

• Candidate should possess knowledge of Regulatory guidelines, Understanding of various dosage forms and development, Basic clinical, pharmaceutical, chemical, analytical subjects. Good in document management, proficient in MS Office.

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