Executive - Regulatory Compliance

Job Description

Title: Executive - Regulatory Compliance

Company Name: DBL Pharmaceuticals Ltd.

Vacancy: --

Age: Na

Job Location: Gazipur (Kashimpur)

Salary: --

Experience:

• 1 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Master of Pharmacy (M.Pharm)

• 1 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Advanced knowledge in MS Suite;

• Excellent interpersonal skills for effective collaboration with internal and external stakeholders;

• Strong personal integrity and professional ethics are essential.

• Prepare and compile regulatory dossiers (CTD, ACTD, country-specific);

• Ensure product compliance with global standards (US-FDA, EMA, WHO, DGDA);

• Review CMC documentation and manage authority queries for fast-track approval;

• Oversee post-approval changes, pharmacovigilance and regulatory compliance from development to submission;

• Coordinate with local/international regulatory bodies and support audits;

• Manage contract manufacturing organizations, including change controls, deviations and complaints;

• Prepare/review SOPs, update product pricing and ensure proper implementation;

• Provide updated regulatory information and guidance to relevant departments.