Snr Regulatory Affairs Pharmacist

Hire Resolve

Johannesburg, Gauteng
Permanent
Full-time

14 days ago

Job SummaryHire Resolve is seeking a Senior Regulatory Affairs Pharmacist to join our client's team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and managing the registration of pharmaceutical products.Responsibilities

Prepare and submit regulatory applications for the registration of pharmaceutical products
Review and analyze regulatory documentation for accuracy and completeness
Develop and maintain relationships with regulatory authorities
Stay updated on changes in regulatory requirements and guidelines
Provide regulatory guidance and support to cross-functional teams
Ensure compliance with relevant regulations and standards
Participate in regulatory audits and inspections
Manage the maintenance and renewal of product registrations
Provide training on regulatory compliance and best practices
Conduct regulatory impact assessments for product changes and updates
Collaborate with global regulatory teams on international registration projects

Requirements:

B. Pharm (Bachelor of Pharmacy)

Registration with the South African Pharmacy Council (SAPC)
Minimum 5 years' experience in Regulatory Affairs (must have experience with human medicine and biologicals)
Experience in product registration (NCE)
Maintenance of dossiers and updates
Pharmacovigilance experience/knowledge of collecting and reporting
Knowledge of SAHPRA submission portals
Launch procedures for new products
Knowledge and experience regarding QA processes, APQRs, customer complaints, etc.
In-depth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa related to dossier submissions and lifecycle management
Knowledge of the Marketing Code
Systems knowledge
Competent and experienced in eCTD submissions
Proficiency in Microsoft Office suite including Word, Excel, and PowerPoint at an Intermediate level
Familiarity with ZAZIBONA processes

Contact Hire Resolve for your next career-changing move.

Salary: negotiable.
Our client is offering a highly competitive salary for this role based on experience.
Apply for this role today, contact Miné Roux at Hire Resolve or on LinkedIn
You can also visit the Hire Resolve website:

or email us your CV: * Alternatively, apply via our portal and emailWe will contact you telephonically in 3 days should you be suitable for this vacancy. If you are not suitable, we will put your CV on file and contact you regarding any future vacancies that arise.Hire ResolveIT/ComputerRecruiterAboutSpecialists in Civil, Structural, Mechanical Engineering, Information Technology, Mining, Manufacturing and Finance Careers! Hire Resolve is one of the larger and more agile South African recruitment companies that focus on placing professionals and skilled people in permanent employment and contract employment. We prefer and focus on working with top quality professionals and candidates in South Africa and Africa. Hire Resolve has successfully placed Engineering, Mining, IT, Manufacturing and Finance professionals with top firms across the Western Cape, Eastern Cape, KwaZulu Natal, Gauteng and in Africa. Hire Resolve has assisted candidates to find jobs at over 100 JSE listed companies of which many are global companies with offices and operations in South Africa and Africa. It is for this reason that we are well respected in the industries we operate in and in the recruitment industry.

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