Regulatory Affairs Officer

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.