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.