Specialist - Regulatory Affairs

at  Julphar

CORE COMPETENCY

• Highly result-oriented with a strong sense of accountability & ownership.
• High communication, interpersonal, and decision skills are required.
• Excellent understanding of Pharmaceutical Business and Planning skills.
• Must have an analytical mind and ability to analyze and summarize data and must be able to communicate technical, scientific, and regulatory information, both written and verbally.
• Ability to multitask, prioritize, and easily adapt to changing situations.
• Strong detail-oriented and must be highly organized, disciplined & motivated.
• Should be ready and willing to learn new things and implement them at the workplace, commit towards work & added tasks.

QUALIFICATIONS / KEY EXPERIENCES / FUNCTIONAL KNOWLEDGE REQUIREMENTS

• Bachelor’s Degree in Pharmacy / any equivalent field.
• At least 2-3 years experience in a similar organization in pharma, Health care, or the medical Industry or training in a scientific area.
• I should have handled a similar role for better fitment.
• Strong command of English & Arabic (communicating, writing, and speaking).
• Proficient in MS Office (MS Excel and MS Word, etc.).
• Strong Knowledge of a specific regulatory discipline and the principles, concepts, and theories governing Regulatory Affairs.

JOB SUMMARY/ MAIN PURPOSE

The role holder is responsible for ensuring the provision of strategies for regulatory projects, resources, costs, time, and clients. The role holder is also accountable for preparing product registration requirements and submissions to the Ministry of Health.
Responsible for all regulatory activities, including dossier assessment, Gap analysis of regulatory Technical work with Health Authorities or/the Food and Drug Administration, coordination with agents and distributors in countries to follow and update registration (renewal and variation status), preparation of variation planning as the approved CCF, and distribution of it along with the team.

KEY RESPONSIBILITIES & KEY RESULT AREAS

• Preparation & submission of renewal files before the expiry date in African countries (Ecuador, Egypt, Ethiopia, Sudan, Tanzania, Uganda & Kenya) as per their requirements to avoid losing registration license.
• Reviewing all the variation files regarding the formula (active & inactive ingredients), additional pack sizes, change in the packaging materials (leaflets, inner & outer packs), the dosage form, increase of shelf life & storage condition for different health authorities (for the above mentioned market) as per their requirements & as per management planning & request .
• Gap analysis preparation, then variation files Preparation for different health authorities as per their current guidelines & as per management request.
• Arrange the sample with approved packaging materials as per country requirements.
• Responsible for responding to all the queries received from countries within the timeline.
• Monitor the performance of the Compliance Program and relate activities continuously, taking appropriate steps to improve its effectiveness.
• Ensure proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required.
• Advise on regulatory strategy and executing specific submissions through regulatory agents.
• Manage all parts of a regulatory project, including overall strategy, resources, costs, time, and clients. Choose the method and processes of work to achieve overall objectives.
• Investigate opportunities for regulatory innovation / promote the use of novel approaches within the team to resolve issues and problems.
• Prepare the Registration Dossiers for the Health Authorities in different countries as per their current guidelines and the preparation of the Technical file for the Drug Control Laboratory.
• Prepare the renewal / re-registration of the products for the different health authorities.
• Notify the Minor Changes regarding the Formula (Active & Inactive Ingredients), Additional Pack Sizes, and Changes in the Packaging Materials (Leaflets, Inner & Outer Packs), the Dosage Form, and Increase Shelf Life & Storage Condition.
• Prepare the required certificates & arrange for the legalization as per the requirements of the different countries, to be included in our Registration Files.
• Responsible for following up on the documents requested by different departments.
• Relate/contribute to developing internal policies, processes, and procedures that support the progression and maintenance of the pharmaceutical portfolio at large.