Sr. Executive, Regulatory Affairs
Job Description
Title: Sr. Executive, Regulatory Affairs
Company Name: Quality Pharmaceuticals (Pvt.) Ltd.
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Full-time
Educational Requirements:
∎ M. Pharm/B. Pharm from any reputed Institution with good academic results.
Experience Requirements:
∎ At least 3 year(s)
Job Responsibilities:
∎ Ensure that a company's products comply with the regulations of the regions where they want to distribute them
∎ Keep up to date with national and international legislation, guidelines and customer practices
∎ Collect and evaluate scientific data from a range of sources
∎ Develop and write clear arguments and explanations for new product licenses and license renewals
∎ Planning, undertaking and overseeing product trials and regulatory inspections
∎ Keeping up to date with changes in regulatory legislation and guidelines
∎ Prepare submissions of license variations and renewals to strict deadlines
∎ Monitor and set timelines for license variations and renewal approvals
∎ Write clear, accessible product labels and patient information leaflets
∎ Plan and develop product trials and interpret trial data
∎ Advise manufacturers on regulatory requirements
∎ Provide strategic advice to senior management throughout the development of a new product.
∎ Undertake and manage regulatory inspections
∎ Review company practices and provide advice on changes to systems
∎ Liaise with, and make presentations to, regulatory authorities
∎ Negotiate with regulatory authorities for marketing authorization.
∎ Specify storage, labelling and packaging requirements.
Additional Requirements:
∎ Age at most 30 years
∎ At least 3 years work experience as production officer in any pharmaceuticals company
∎ Experienced person will get preference.
∎ Good interpersonal and communication skills.
∎ Excellent Communication Skill in Bangla and English.
∎ Ability to deal with people from diverse perspectives regulatory authorities.
∎ Good command over MS- Office, Excel and Power Point
∎ Self-motivated and proactive in producing and delivering outputs.
Application Deadline: August 8, 2019
Company Information:
∎ Quality Pharmaceuticals (Pvt.) Ltd.
∎ Address : 8/3, Segun Bagicha, Dhaka 1000.
∎ Web : www.qpl.com.bd
Category: Medical/Pharma
Source: bdjobs.com
Deadline Expired on 8th Aug 2019
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