Regulatory Affairs Officer at a Leading Pharmaceutical Company


Posted on: Thu 20-06-2024

A Leading Pharmaceutical Company is recruiting to fill the position below:

Job Title: Regulatory Affairs Officer

Location: Lagos

Employment Type: Full-time

Job Description

  • To ensure the appropriate licensing, marketing and legal compliance of cosmetics, pharmaceutical 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 licenses and license 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.

Qualifications

  • A Bachelor of Pharmacy (Pharmacist Only)
  • MBA qualification will be an added advantage.
  • Minimum of 2 years’ experience in the Pharmaceutical sector.

Skills Requirements:

  • Negotiation skills
  • Analytical skills
  • Time management skills
  • Problem-solving skills
  • Presentation and reporting skills
  • Communication and Interpersonal skills

How to Apply

Interested and qualified candidates should send their CV and Application Letter to: [email protected] using the Job Title as the subject of the mail.

Note: Only Shortlisted candidates will be contacted.