Regulatory Affairs Officer at Vixa Pharmacy

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 added advantage.
• Minimum of 2 years experience in Pharmaceutical sector.

Skills Requirements:

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