Executive/Sr. Executive (Regulatory & Affairs)

Job Description

Title: Executive/Sr. Executive (Regulatory & Affairs)

Company Name: Shinil Pharma Ltd.

Vacancy: 01

Age: 28 to 40 years

Job Location: Dhaka (Naya Paltan)

Salary: Negotiable

Experience:

• 2 to 4 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Livestock, Animal/Plant Breeding

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)
• Bachelor of Science (BSc) in Chemistry
• Bachelor of Science (BSc)

• 2 to 4 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Livestock, Animal/Plant Breeding

• Age 28 to 40 years

• Knowledge of national (DGDA) and international regulatory guidelines (ICH, WHO, FDA, EMA) preferred.
• Strong documentation, analytical, and communication skills.

• Prepare, compile, and submit dossiers for new product registration, re-registration, and variations to the relevant regulatory authorities (DGDA, WHO, FDA, GLP, etc.).

• Maintain up-to-date knowledge of local and international pharmaceutical regulations, guidelines, and requirements.

• Ensure compliance of product labeling, packaging, and promotional materials with regulatory standards.

• Liaise with cross-functional teams (R&D, QA, Production, Marketing) to collect technical documents for submission.

• Monitor the progress of regulatory submissions and proactively follow up with authorities to expedite approvals.

• Maintain proper documentation and regulatory database to ensure timely renewals and approvals.

• Support audits, inspections, and respond to queries from regulatory bodies.

• Provide regulatory intelligence to management regarding new policies, amendments, or guidelines

• T/A,Mobile bill,Tour allowance
• Salary Review: Yearly
• Festival Bonus: 2

Attractive and competitive salary package.