Executive, International Regulatory Affairs

Job Description

Title: Executive, International Regulatory Affairs

Company Name: US FDA Approved Leading Pharmaceuticals Company

Vacancy: --

Age: At most 35 years

Job Location: Dhaka

Salary: Negotiable

Experience:

• 2 to 3 years
• The applicants should have experience in the following business area(s): Healthcare/Lifestyle product, Pharmaceutical/Medicine Companies

• Minimum M. Pharm or B. Pharm (5 years professional degree) from reputed university.

• 2 to 3 years
• The applicants should have experience in the following business area(s): Healthcare/Lifestyle product, Pharmaceutical/Medicine Companies

• Age At most 35 years

• Proficiency in MS Office applications, particularly Word and Excel.

• Good written and verbal communication skills in English.

• Strong organizational skills, attention to detail, and ability to meet deadlines.

• Ability to work independently and coordinate effectively with cross-functional teams.

• Prepare, compile, and submit product registration dossiers for semi-regulated markets.

• Prepare regulatory documents in accordance with country-specific requirements.

• Coordinate with internal departments to collect required technical documents and information.

• Review regulatory documents to ensure accuracy, completeness, and compliance.

• Respond to regulatory queries and deficiencies raised by health authorities.

• Coordinate with overseas partners and agents regarding product registration activities.

• Manage product registration renewals, variations, and other post-approval activities.

• Monitor registration progress and follow up to ensure timely approvals.

• Maintain updated registration databases, submission records, and regulatory documents.

• Stay updated on regulatory guidelines and requirements of assigned markets.