Assistant Manager International Regulatory Affairs

Octavius Pharma

5 - 7 years

7 - 10 Lacs

ahmedabad

Posted:1 day ago| Platform:

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Skills Required

team management dossier preparation actd ctd row market drug regulatory affairs fda dossier compilation review cis leadership skills latin america ich legal documentation regulatory affairs latam dossier

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements.
Responsible for final review of dossier before submission.
To coordinate with technical team for documents required for dossier.
Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc.
Reviewing artwork for products as per relevant regulatory authority requirements.
To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements;
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness.
Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives.

Preferred candidate profile

Qualification: B. Pharm and M. Pharm

Experience: Minimum 5-7 years in ROW market for Formulation Dossier preparation and submission

Perks and benefits

Salary: 55,000 to 80,000 per month

Mediclaim

Bonus

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