Regulatory Affairs - Emerging/ ROW Market

Unison Pharmaceuticals, one of the fastest growing organization is looking for Multiple positions in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission.

Role and responsibilities

1. Responsible for preparing/reviewing various regulatory documents for Emerging markets (South East Asia, Africa, CIS, Latin America, Gulf Countries) such as,

• Dossiers in ACTD, CTD and in country specific format.
• Variation filling, renewal fillings, Query response, Site registration applications, Tender fillings.
• Legal Applications related to local FDA\CDSCO like FSC, COPP, Product permissions, WHO GMP inclusions.
• Responsible for coordinating with Cross functional teams for timely receipt of technical documents.
• To verify and approve all technical documents in line with current regulatory requirements.
• Regulatory assessment of CCN/Deviation for Impact assessment.
• Artwork development, amendments and maintenance without adversely affecting the business continuity to implement regulatory changes.
• Maintain various regulatory status.

2. Monitoring of product lifecycle as per regulatory requirement.

3. Literature search, data collection, evaluation to meet the requirement of above job responsibilities.

Candidate should have detailed knowledge on:

• Regulatory requirements for submission of product dossiers.
• Registration samples submission in ROW countries.
• Candidate must have Good in written and verbal communications.
• Candidate must have basic knowledge of Microsoft Word, Excel & Power Point

Interested candidates may also email their resume to maitrivakil@unisonpharmaceuticals.com