Regulatory Affairs Officer

Candidate must possess at least Bachelor's Degree in Pharmacy/Pharmacology.With Valid PRC license.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, medicineExperience 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, and 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, and labeling review among others to ensure compliance with the company FDA regulations for business activities.

Key Skills, Knowledge & expertise:

Familiarity and experience with Drugs, Food Products, Food supplements, Herbal, Traditional medicines, Prebiotics, Probiotics, devices, and other hospital/healthcare practices. Knowledge of standard office software programs including e-dossier management system, spreadsheet, word-processing, email applications, and PowerPoint.Substantial experience and understanding of the role of RA and regulatory requirements in the Life Sciences Industry including ICH requirements and regional requirements and understanding of current trends in the local market. Good project management skills with the ability to prioritize and multitask.Strong collaborative skills and ability to work well with internal cross-functional teams and external stakeholders.A flexible "can do" attitude is 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; make important decisions that impact the department and ensure they are proactively and appropriately communicated.Good communication skills, especially as it relates to transparency, collaboration, and the ability to work across communication channels.Self-motivated, able to work independently, enjoy 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.