Executive, Regulatory Affairs
Job Description
Title: Executive, Regulatory Affairs
Company Name: A reputed Pharmaceuticals Company
Vacancy: 01
Age: 27 to 35 years
Location: Dhaka
Salary: Negotiable
Experience:
∎ 2 to 3 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies
Published: 8 Jan 2025
Education:
∎ Master of Pharmacy (M.Pharm)
∎ Additional Certifications in areas like Compliance Management, Industrial Safety, or Environmental Regulation would also be advantageous.
Requirements:
Additional Requirements:
∎ Age 27 to 35 years
Responsibilities & Context:
∎ Studying scientific and legal documents; Gathering, evaluating, organizing, managing and collating information in a variety of formats
∎ Ensuring compliance with all regulated authorities.
∎ Maintaining familiarity with company product ranges
∎ Planning, undertaking and overseeing product trials and regulatory inspections
∎ keeping up-to-date with changes in regulatory legislation and guidelines
∎ Analyzing complicated information, including trial data offering advice about company policies, practices and systems
∎ Obtaining marketing permission outlining requirements for labelling, storage and packaging
∎ Providing advice about regulations to manufacturers/scientists
∎ Writing comprehensible, user-friendly, clear product information leaflets and labels
∎ Ensuring that quality standards are met and submissions meet strict deadlines Preparing documentation.
∎ Ensuring that a company's products comply with the regulations; keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to
∎ Developing and writing clear arguments and explanations for new product licenses and license renewals
∎ Preparing submissions of license variations and renewals to strict deadlines; monitoring and setting timelines for license variations and renewal approvals
∎ Working with specialist computer software and resources; writing clear, accessible product labels and patient information leaflets
∎ Planning and developing product trials and interpreting trial data
∎ Advising scientists and manufacturers on regulatory requirements; providing strategic advice to senior management throughout the development of a new product
∎ Project managing teams of colleagues involved with the development of new products
∎ Undertaking and managing regulatory inspections; reviewing company practices and providing advice on changes to systems
∎ Liaising with, and making presentations to, regulatory authorities
∎ negotiating with regulatory authorities for marketing authorization
∎ Specifying storage, labelling and packaging requirements.
∎ Studying scientific and legal documents; Gathering, evaluating, organizing, managing and collating information in a variety of formats
∎ Ensuring compliance with all regulated authorities.
∎ Maintaining familiarity with company product ranges
∎ Planning, undertaking and overseeing product trials and regulatory inspections
∎ keeping up-to-date with changes in regulatory legislation and guidelines
∎ Analyzing complicated information, including trial data offering advice about company policies, practices and systems
∎ Obtaining marketing permission outlining requirements for labelling, storage and packaging
∎ Providing advice about regulations to manufacturers/scientists
∎ Writing comprehensible, user-friendly, clear product information leaflets and labels
∎ Ensuring that quality standards are met and submissions meet strict deadlines Preparing documentation.
∎ Ensuring that a company's products comply with the regulations; keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to
∎ Developing and writing clear arguments and explanations for new product licenses and license renewals
∎ Preparing submissions of license variations and renewals to strict deadlines; monitoring and setting timelines for license variations and renewal approvals
∎ Working with specialist computer software and resources; writing clear, accessible product labels and patient information leaflets
∎ Planning and developing product trials and interpreting trial data
∎ Advising scientists and manufacturers on regulatory requirements; providing strategic advice to senior management throughout the development of a new product
∎ Project managing teams of colleagues involved with the development of new products
∎ Undertaking and managing regulatory inspections; reviewing company practices and providing advice on changes to systems
∎ Liaising with, and making presentations to, regulatory authorities
∎ negotiating with regulatory authorities for marketing authorization
∎ Specifying storage, labelling and packaging requirements.
Skills & Expertise:
Compensation & Other Benefits:
∎ Mobile bill, Weekly 2 holidays
∎ Salary Review: Yearly
∎ Festival Bonus: 2
Workplace:
∎ Work at office
Employment Status: Full Time
Gender:
∎ Only Male
Job Location: Dhaka
Company Information:
∎ A reputed Pharmaceuticals Company
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 2 Feb 2025
Category: Others
