Regulatory Affairs Executive / Assistant Manager

Asence Pharma

8 - 12 years

10 - 14 Lacs

Vadodara

Posted:11 hours ago| Platform:

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Skills Required

Regulatory Affairs CTD eCTD formats regulatory submission tools document management systems

Work Mode

Work from Office

Job Type

Full Time

Job Description

About the Role:

Regulatory Affairs Executive/Assistant Manager

Key Responsibilities:

Prepare, compile, and review regulatory submissions (CTD/eCTD formats) for product registrations, renewals, and variations as per regional and international guidelines.
Ensure timely submission and follow-up of applications with regulatory authorities.
Maintain up-to-date knowledge of changes in drug regulatory environments and communicate impacts to relevant departments.
Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Supply Chain) to gather necessary documentation.
Maintain regulatory documentation, databases, and records in compliance with internal procedures and regulatory standards.
Assist in handling product labelling, artwork approvals, and packaging compliance.
Respond to regulatory queries and deficiencies from health authorities in a timely manner.

Candidate Profile:

Bachelors or Masters degree in Pharmacy, Life Sciences, or related field.
Minimum of 8 years of experience in Regulatory Affairs within the pharmaceutical sector.
Strong understanding of regulatory frameworks.
Experience with dossier preparation in CTD/eCTD formats.
Familiarity with regulatory submission tools and document management systems.
Excellent communication skills, both written and verbal.
Strong analytical and problem-solving skills.
Detail-oriented with the ability to manage multiple projects and deadlines.

More Jobs at Asence Pharma

Regulatory Affairs Executive / Assistant Manager

Vadodara

8.0 - 12.0 yrs

INR 10 - 14 Lacs

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