Yesterday
SENIOR REGULATORY AFFAIRS PHARMACISTS
Jordan Human Resources
South Africa, Johannesburg
Pharmaceutical Client looking for a Senior Regulatory Affairs Pharmacist, to support the regulatory team to provide superior regulatory services to relevant departments within the company and with external partners and to control and manage a portfolio of product outputs. Qualifications Bachelor’s Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council Experience +-5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities. Demonstrable experience across the product development, commercialization and maintenance lifecycle Sound project management capabilities Proven ability to consistently deliver to quality, time and cost standards Good Manufacturing Practices (GMP) Pharmaceutical production experience or exposure to supplement regulatory knowledge. Core competencies Experience in use of CTD software builder and compilation of eCTD dossierapplications. IT skills including Microsoft Office, ability to prioritise and work to tight deadlines. Systems and operations analysis, basic cost management skills, active learning and strategic thinking. Cross Functional skills: Ability to network, liaise and negotiate with others Ability to set standards and objectives and monitor progress Complex problem solving and decision-making skills, customer relationships, development of people. Must demonstrate responsibility, excellence and collaboration and alignwith company values. Key Job Outputs Manage work streams for- and report on the assigned portfolio of products: Internal product queries from relevant departments External product queries from the SAHPRA, other MRA’s and third party stakeholders. Establish regulatory priorities and allocate resources and workloads Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards We’ve been building better teams since 2004 with operating offices in Gauteng and Cape Town, and since 2019 extended our reach with an active international footprint. In September 2019, Vinton Holdings (Pty) Ltd acquired and became the proud owner of JorDan Human Resources. Trusted by globally-recognised companies within the medical locum, perm and temporary markets, our flexible approach and network of legendary individuals continues to create real impact and help solve your business challenges. Fortunately, you don't have to wonder where to hire Phlebotomists, Medical Technologists, Registered Nurses&Enrolled Nurses anymore. JorDan HR is the premier medical staffing agency for registered health professionals. Whatever the problem, we’re part of the solution. The goal is to develop customised approaches that fit. Period. Our size is our strength. We’re small enough to care but big enough to make an impact. Genuine passion and enthusiasm for what we do, combined with a no bull attitude and a deep understanding of our sectors enable us to respond and adapt swiftly to clients’ needs. Our group mission is to enhance our candidates’ lives as well as contributing positively to our clients‘ bottom line. Our established international footprint offers dedicated personal service, strong relationship building, ethical business practices, networking and professional search and recruitment, adding value within our chosen specialty industries. Our home in Africa and our deep roots in the African People Management field gives us the ability to provide Key Insights and Actionable Market Intelligence to leading organizations wishing to enter the African market or expand their reach in Africa. Compliance at its best. With continuous improvement in compliance and vetting procedures, JorDan HR, together with our independent verification partners, offer you peace of mind that is unmatched by competitors. We move, connect, hustle, and stay humble. #J-18808-Ljbffr
Attention! You will be redirected to another site