• Candidate must possess at least Bachelor's Degree / Master's Degree in Pharmacy/Pharmacology.
• At least 5 Year(s) of working experience in the related field is required for this position.
• Required Skill(s): microsoft word, e-dossier management, regulatory affairs, negotiation skills, healthcare, medicine
• Preferably Supervisor/5 Yrs & Up Experienced Employee specialized in Healthcare - Pharmacy or equivalent.
• Experience in preparing a product dossier with ICH guidelines.
• Experience in working on an e-dossier management system.

Roles & Responsibilities:

• Focus on co-ordinating & documenting regulatory processes such as inspections, license renewals, registrations.
• Compiling & preparing materials for submission to regulatory agencies related to regulatory initiatives 
• Maintaining regulatory compliance of products for the following RA activities: initial, renewal, variations, promo, permits, marketing materials, labelling review among others to ensure compliance of the company FDA regulations for business activities.

Key Skills, Knowledge & expertise:

• Familiarity and experience with Drugs, Food products, Food supplement, Herbal , Traditional medicines , Per-biotics , Pro-biotics, devices and other hospital/healthcare practices. 
• Knowledge of standard office software programs including e-dossier management system, spreadsheet, word-processing, email applications and Power Point.
• Substantial experience and understanding of role of RA and regulatory requirements in Life Sciences Industry including ICH requirements and regional requirements and understand current trends in the local market. 
• Good project management skills with the ability to prioritize and multi-task.
• Strong collaborative skills and ability to work well with internal cross-functional teams and external stakeholders.
• Flexible "can do" attitude needed to thrive in an ambitious and fast-growing company.
• Very good influencing and negotiating skills. 
• Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
• Excellent decision-making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated.
• Good communication skills, especially as it relates to transparency, collaboration and ability to work across communication channels.
• Self-motivated, able to work independently, enjoys a good challenge and remains focused even in the face of setbacks.
• Flexible, determined, eager to experiment and has an open mind. 
• An independent and reliable way of working, takes initiative and ownership.
• High levels of integrity and honesty.