Regulatory Affairs Officer

About ABH

ABH Partners Plc is a leading and prominent consultancy and management firm. With over Seventeen years of experience, our company specializes in providing high-quality, client-centered technical and management services, including quality education, operational research, training, consultancy, and project implementation. Currently, we are looking for an ambitious, dynamic, and experienced  Regulatory Affairs Officer  to join our vibrant team and help drive our marketing initiatives to achieve organizational goals.

Post title:  Regulatory Affairs Officer

Required number: 1 (One)

Place of Work: Addis Ababa

Employment Type: Full Time

Reporting to:  Director, Alliance Medical Solutions (AMS) Division

Starting Date:  Immediately after contract agreement concluded

Key Responsibilities:

• Ensure that a company’s products comply with the regulations of the regions where they want to distribute them
• Keep up to date with national and international legislation, guidelines and customer practices
• Respond to queries from medical bodies like the Ethiopian Food and Drugs Authority.
• Collect, collate and evaluate scientific data from a range of sources
• Develop and write clear arguments and explanations for new product licenses and license renewals
• Prepare submissions of license variations and renewals to strict deadlines
• Monitor and set timelines for license variations and renewal approvals
• Work with specialist computer software and resources
• Write clear, accessible product labels and patient information leaflets
• Plan and develop product trials and interpret trial data
• Advise scientists and manufacturers on regulatory requirements
• Provide strategic advice to senior management throughout the development of a new product
• Project manage teams of colleagues involved with the development of new products
• Oversee product trials and interpret trail data
• Undertake and manage regulatory inspections
• Review company practices and provide advice on changes to systems
• Liaise with, and make presentations to, regulatory authorities
• Negotiate with regulatory authorities for marketing authorization
• Take part in the development of marketing concepts and approve packaging and advertising before a product’s release.
• Studying scientific and legal documents to check they meet legal requirements.
• Maintaining familiarity with company product ranges.
• Planning, undertaking and overseeing product trials and regulatory inspections.
• Offering advice about regulations, company policies, practices and systems.
• Outlining requirements for labelling, storage and packaging, and approving information leaflets and labels.

Qualifications:

• ?Minimum three and above Years of practical experience in similar Position
• MSc/BSc degree in pharmacy, medicinal chemistry, biomedical science, Bio Medical Engineering, pharmaceutical or similar fields.
• Relevant experience in regulatory processes and understanding of legislation in the field
• Ability to combine scientific knowledge with legal and business issues to meet the required legislation.
• Ability to take in complex technical information and make sense of it.
• Ability to grasp new concepts quickly to assimilate and evaluate scientific data.