Regulatory Affairs officerSRS Life Sciences Inc.

JOB DESCRIPTION
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.
OTHER JOB REQUIREMENTS
Education
Bachelor's/College Degree
Field of study
Pharmacy/Pharmacology
Specialization
Pharmacy
Negotiation Skills, Medicine, e-dossier management, regulatory affairs