Executive Regulatory Affairs

Job Description

Title: Executive Regulatory Affairs

Company Name: A Reputed Pharmaceuticals Company.

Vacancy: Not specific

Job Location: Dhaka

Employment Status: Full-time

Educational Requirements:
∎ B. Pharm/M. Pharm from any reputed institution with good academic results.

Experience Requirements:
∎ At most 1 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, labeling and packaging requirements.

Additional Requirements:
∎ Age at least 30 years
∎ Only males are allowed to apply
∎ Age not more than 30 years
∎ 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.

Salary: Negotiable

Compensation & Other Benefits:
∎ As per Company Rules.

Application Deadline: March 31, 2020

Company Information:
∎ A Reputed Pharmaceuticals Company.

Category: Medical/Pharma

Read Before Apply: Write the post name in Email Subject Line.

Source: bdjobs.com

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