Role & Responsibility:
*The role of Regulatory Affairs Officer focuses on coordinating and documenting regulatory processes, such as inspections, license renewals, or registrations; compiling and preparing materials for submission to regulatory agencies related to regulatory initiatives;
*Maintaining regulatory compliance of products for the following regulatory activities: initial, renewal, variations, promo permits, marketing materials, labelling review, among others, to ensure compliance of the company to FDA regulations for business continuity.
*As part of a global team, active participation in cross-functional teams (Supply Chain, Marketing, Medical Affairs & QA) within the company is a critical part of this role. The provision of regulatory expertise and insight as well as updates on current local regulations and potential changes that will impact the business environment is a fundamental part of the role and as such good communication skills and proactiveness are highly prized.
Key Skills & Knowledge Required:
- 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 in 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.
BA/BS/University degree required, Life Sciences/ Health Sciences preferred.
Masters in Regulatory Affairs
• Minimum 5 year experience in performing regulatory affairs responsibilities from the Pharma (Drugs) and/or Medical Device/ Food Industry / food supplements of which at least 2 years are performed in a supervisory/specialist level.
• Experience in preparing a product dossier as per ICH guidelines.
• Experience of working on a e-dossier management system.