Regulatory Affairs Pharmacist Specialist
1 month ago
Emporium Job Overview
">We are seeking a seasoned Regulatory Affairs Specialist to join our team at Emporium, contributing to the development of high-quality pharmaceutical products. The successful candidate will be responsible for managing regulatory activities and ensuring compliance with relevant standards.
">About the Role
">This is an exciting opportunity for a highly motivated and experienced professional to take on a key role in shaping the future of our regulatory affairs department. As a Senior Regulatory Affairs Professional, you will work closely with cross-functional teams to develop and implement regulatory strategies that meet the highest standards.
">Key Responsibilities
">- ">
- Manage regulatory submissions, including preparation and review of documents for various regulatory agencies;">
- Develop and maintain relationships with regulatory authorities to ensure timely and effective communication;">
- Collaborate with internal stakeholders to identify and mitigate regulatory risks;">
- Conduct gap analysis and due diligence to ensure compliance with regulatory requirements;">
- Prepare and submit variations, renewals, and other documentation as required;">
- Stay up-to-date with regulatory developments and updates, applying this knowledge to inform strategic decisions;">
- Mentor and train junior team members to enhance their skills and expertise;">
- Identify opportunities for process improvements and implement changes to increase efficiency and effectiveness.">
- ">
Requirements
">To be successful in this role, you will need:
">- ">
- A Bachelor's Degree in Pharmacy or a related field;">
- At least 5 years of experience in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices;">
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle;">
- Sound project management capabilities, with the ability to prioritize tasks and manage multiple projects simultaneously;">
- Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders;">
- Strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions;">
- Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint;">
- Experience with CTD software builder and eCTD dossier applications.">
- ">
Benefits
">We offer a competitive salary and benefits package, including:
">- ">
- An estimated salary range of R900,000 - R1,000,000 per annum;">
- A comprehensive benefits package, including medical aid, pension fund, and leave entitlements;">
- Opportunities for career growth and professional development;">
- A dynamic and supportive work environment;">
- A chance to work on exciting projects and contribute to the success of Emporium.">
- ">
How to Apply
">If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your CV and cover letter, to jobsemporium.co.za. Use POS2432 – Snr RA Pharma CAM in the subject line.
">Company Overview
">Emporium is a leading company in the pharmaceutical industry, dedicated to developing innovative solutions that improve people's lives. We value excellence, integrity, and collaboration, and we are committed to making a positive impact on society.
">Contact Information
">Please note that all applications will be treated confidentially, and we thank all applicants for their interest. However, only shortlisted candidates will be contacted for further consideration.
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