Sr. Executive / Executive, International Regulatory Affairs

Job Description

Title: Sr. Executive / Executive, International Regulatory Affairs

Company Name: US FDA Approved Leading Pharmaceuticals Company

Vacancy: --

Age: At most 45 years

Job Location: Dhaka

Salary: Negotiable

Experience:

• 2 to 6 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Healthcare/Lifestyle product

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

• 2 to 6 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Healthcare/Lifestyle product

• Age At most 45 years

• Excellent communication skills, especially in English.

• Excellent verbal, written and presentation skills.

• Good computer operating skills.

• Knowledge of global pharmaceuticals market & regulatory system.

• Dedication, sincerity, teamwork, management skills.

• Authoring and compiling high quality CTD dossier across regions.

• Effectively study, research and collate documentation requirements for dossier compilation.

• Reviewing and assessing the adequacy of the CMC, administrative & clinical documents.

• Interpreting CMC data to ensure accuracy in filings.

• To research and understand up-to-date regional regulatory requirements (Europe, Australia, North and South America & others) to ensure regulatory compliance.

• Developing Packaging artworks as per country specific requirements.

• Ensuring ‘Product Lifecycle Management’ by submitting renewals, variations and labeling updates.

• To be responsible and accountable for overall marketing authorization activities of assigned countries.