Regulatory Affairs Officer at Vixa Pharmacy

Job Overview

Location
Lagos, Lagos
Job Type
Full Time
Date Posted
9 days ago

Additional Details

Job ID
126545
Job Views
28

Job Description






Job Description




  • To ensure the appropriate licensing, marketing and legal compliance of pharmaceutical, cosmetics and medical products in order to control the safety and efficacy of products.

  • Responsible for completing reports and applying for any licenses required for operation.

  • Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA).



Roles and Responsibilities




  • Ensuring manufactured products are appropriately licensed, produced and marketed.

  • Negotiating with regulatory authorities for marketing authorization.

  • Developing and writing clear arguments and explanations for new product licences and licence renewals.

  • Ensuring that a company’s products comply with regulations.

  • Providing advice about regulations to manufacturers/scientists.

  • Providing strategic advice to senior management throughout the development of a new product.

  • Writing comprehensible, user-friendly, clear product information leaflets and labels.

  • Undertaking and managing regulatory inspections.

  • Collecting, collating and evaluating scientific data that has been researched by colleagues.

  • Keeping up to date with changes in regulatory legislation and guidelines.

  • Advising scientists and manufacturers on regulatory requirements.

  • Ensuring that quality standards are met and submissions meet strict deadlines.

  • Reviewing company practices and providing advice on changes to systems.

  • Planning, undertaking and overseeing product trials and regulatory inspections.



Qualifications




  • A Bachelor of Pharmacy. Pharmacology, BSC Biochemistry, Microbiology, and other science related courses

  • MBA Qualification will be added advantage.

  • Minimum of 3 years’ experience in Regulatory Affairs sector.

  • Below 35 years.



Skills Requirements:




  • Negotiation skills

  • Analytical skills

  • Time management skills

  • Problem-solving skills

  • Presentation and reporting skills

  • Communication and Interpersonal skills

  • IT skills.



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