Regulatory Affairs Officer at a Well-established Nigerian Pharmaceutical Company

We are a well-established Nigerian Pharmaceutical Company that have come of age with an imposing record of more than 10 years of meeting the needs in healthcare through a range of globally sourced, Best-In-Class-Drugs. We were incorporated in 1998 with the sole aim of manufacturing and marketing Pharmaceutical products.

We are 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 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.

Application Closing Date
14th August, 2024.