FEATURED JOB

Regulatory Operations Associate

Tevapharm India Pvt. Ltd.

0 Years

30000 - 40000 Monthly

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Posted: 19 Aug 26

Job Description

Job Summary

The Regulatory Affairs professional is responsible for ensuring that products comply with applicable regulatory requirements and standards. The role involves preparing and maintaining regulatory documentation, coordinating product registrations and submissions, and communicating with regulatory authorities and internal stakeholders.

Key Responsibilities

Prepare, compile, review, and submit regulatory documents and applications.
Support product registration, renewal, variation, and licensing activities.
Ensure compliance with applicable national and international regulations.
Maintain regulatory dossiers, certificates, licenses, and technical documentation.
Monitor changes in regulatory requirements and assess their impact.
Coordinate with R&D, Quality Assurance, Manufacturing, Clinical, and other departments.
Respond to queries from regulatory authorities and customers.
Support audits and inspections related to regulatory compliance.
Maintain accurate regulatory databases and submission records.
Assist in developing and implementing regulatory strategies for new and existing products.

Required Qualifications

Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related field.
Knowledge of regulatory guidelines and submission requirements.
Good understanding of GMP, GxP, ICH, FDA, EMA, CDSCO, or other applicable regulations, depending on the industry.
Strong documentation, communication, and analytical skills.
Ability to work effectively in cross-functional teams.

Preferred Skills

Experience in pharmaceutical, medical device, biotechnology, or healthcare regulatory affairs.
Knowledge of CTD/eCTD dossier preparation.
Familiarity with regulatory submission systems and documentation management.
Attention to detail and strong organizational skills.