Job Description
Title: Deputy Manager/ Assistant Manager International Marketing (Regulatory)
Company Name: Advanced Chemical Industries Limited (ACI)
Vacancy: --
Location: Dhaka (Gulshan)
Minimum Salary: Negotiable
Experience:
∎ At least 5 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies
Published: 13 Aug 2024
Education:
∎ Bachelor of Science (BSc) in Pharmacy, Bachelor of Science (BSc) in Chemistry, Bachelor of Science (BSc) in Biomedical Science, Bachelor of Science (BSc) in Biochemistry, Master of Science (MSc) in Pharmacy
Requirements:
Additional Requirements:
∎ Minimum 2-3 years of experience in preparing and submitting regulatory applications for product registration in international market.
∎ Solid understanding and hands-on experience of handling the regulatory framework and guidelines for pharmaceutical products.
∎ Excellent communication and interpersonal skills to effectively work with cross-functional teams and regulatory authorities.
∎ Knowledge of pharmacovigilance requirements and post-market surveillance activities.
∎ Exposure to GMP audit & eCTD filing.
∎ Minimum 2-3 years of experience in preparing and submitting regulatory applications for product registration in international market.
∎ Solid understanding and hands-on experience of handling the regulatory framework and guidelines for pharmaceutical products.
∎ Excellent communication and interpersonal skills to effectively work with cross-functional teams and regulatory authorities.
∎ Knowledge of pharmacovigilance requirements and post-market surveillance activities.
∎ Exposure to GMP audit & eCTD filing.
Responsibilities & Context:
∎ Perform functions like Regulatory compliance, CTD filing, planning, meet project timelines.
∎ Dossier preparation and review as per country specific guideline/CTD guideline·
∎ Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement)·
∎ Preparation, review & release of artworks & sales order as per country approval·
∎ Variation documents preparation and filing as per country requirements·
∎ Timely dispatch of tender documents to country/parties as per deadline.
∎ Ensure compliance of products with the current regulations, monitoring of international legislation, guidelines and customer practices, planning and communicating with external agencies.
∎ Anticipate regulatory obstacles for trouble-shooting in development activities and emerging issues throughout the product lifecycle.
∎ Handle post-approval variations, support for smooth launch and uninterrupted supplies.
∎ Semi Regulated ROW Market (Asia, Africa, Latin America, Middle East, CIS)
∎ Perform functions like Regulatory compliance, CTD filing, planning, meet project timelines.
∎ Dossier preparation and review as per country specific guideline/CTD guideline·
∎ Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement)·
∎ Preparation, review & release of artworks & sales order as per country approval·
∎ Variation documents preparation and filing as per country requirements·
∎ Timely dispatch of tender documents to country/parties as per deadline.
∎ Ensure compliance of products with the current regulations, monitoring of international legislation, guidelines and customer practices, planning and communicating with external agencies.
∎ Anticipate regulatory obstacles for trouble-shooting in development activities and emerging issues throughout the product lifecycle.
∎ Handle post-approval variations, support for smooth launch and uninterrupted supplies.
Skills & Expertise:
Compensation & Other Benefits:
∎ Performance bonus, Profit share, Provident fund, Weekly 2 holidays, Medical allowance, Mobile bill, Tour allowance, Gratuity
∎ Lunch Facilities: Partially Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
Employment Status: Full Time
Job Location: Dhaka (Gulshan)
Company Information:
∎ Advanced Chemical Industries Limited (ACI)
∎ ACI Centre, 245 Tejgaon Industrial Area, Dhaka-1208.
∎ Pharmaceuticals; Agribusiness; Consumer Brands.
Address::
∎ ACI Centre, 245 Tejgaon Industrial Area, Dhaka-1208.
∎ Pharmaceuticals; Agribusiness; Consumer Brands.
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 12 Sep 2024
Category: Medical/Pharma
