Regulatory Affairs (ROW Market)

Unison Pharmaceuticals; Ahmedabad District; On-site; INR 450,000 - 700,000; Full time

Job summary

Unison Pharmaceuticals is seeking an Executive/Sr. Executive (Regulatory) for its Vastrapur Office. The candidate should hold M. Pharm and will handle regulatory submissions across Emerging markets, coordinate with cross-functional teams, and ensure compliance with current regulatory requirements.

The role includes reviewing dossiers, variation fillings, site registrations, and maintaining regulatory status. Email resumes to [e-mail]. Team HR, Unison Pharmaceuticals

Qualifications

• M. Pharm is required.

Responsibilities

• Work on variety of Regulatory related submissions including but not limited to the following functions: 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; Coordinating with Cross functional teams for timely receipt of technical documents; 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; Maintain various regulatory status.
• Monitoring of product lifecycle as per regulatory requirement.
• Literature search, data collection, evaluation to meet the requirement of above job responsibilities.

Education

M. Pharm

Job description

Unison Pharmaceuticals, one of the fastest growing organization is looking for below profile:

• Designation: Executive/ Sr. Executive
• Job Location: Vastrapur Office, 2nd and 4th Saturday Off
• Qualification: M. Pharm

Roles and Responsibilities:

Work on variety of Regulatory related submissions including but not limited to the following functions:

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.

Interested candidates may also email their resume to [e-mail]

Team HR

Unison Pharmaceuticals