Job opportunity
Regulatory Affairs Specialist - Pharmaceuticals
Placements24
About the Role
Our client is seeking a detail-oriented and experienced Regulatory Affairs Specialist to manage and coordinate regulatory activities for their pharmaceutical products in Kimberley . You will be responsible for ensuring that all products comply with national and international regulatory requirements, from product registration to post-market surveillance. This role requires a deep understanding of regulatory submissions, guidelines, and a proactive approach to navigating the complex regulatory landscape. The ideal candidate will be instrumental in facilitating the timely approval and market access of new and existing pharmaceutical products, working within a dedicated team committed to regulatory excellence in Kimberley .
Key Responsibilities
Prepare, submit, and manage regulatory applications for product registration and variations.
Ensure compliance with all relevant local and international pharmaceutical regulations and guidelines.
Liaise with regulatory authorities (e.g., SAHPRA) on submission status and inquiries.
Review and approve promotional materials to ensure regulatory compliance.
Monitor changes in regulatory legislation and assess their impact on the company's products and operations.
Requirements
Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
Minimum of 4 years of experience in pharmaceutical regulatory affairs.
In-depth knowledge of regulatory submission processes and requirements in South Africa and key international markets.
Experience with regulatory databases and submission software.
Strong analytical, problem-solving, and communication skills.
Benefits
Competitive salary and performance-based incentives.
Comprehensive health insurance and retirement plan.
Support for professional development and regulatory training.
A collaborative work environment with opportunities for growth.
Key role in ensuring compliance and market access for pharmaceuticals in Kimberley .
#J-18808-Ljbffr
Apply on source site Our client is seeking a detail-oriented and experienced Regulatory Affairs Specialist to manage and coordinate regulatory activities for their pharmaceutical products in Kimberley . You will be responsible for ensuring that all products comply with national and international regulatory requirements, from product registration to post-market surveillance. This role requires a deep understanding of regulatory submissions, guidelines, and a proactive approach to navigating the complex regulatory landscape. The ideal candidate will be instrumental in facilitating the timely approval and market access of new and existing pharmaceutical products, working within a dedicated team committed to regulatory excellence in Kimberley .
Key Responsibilities
Prepare, submit, and manage regulatory applications for product registration and variations.
Ensure compliance with all relevant local and international pharmaceutical regulations and guidelines.
Liaise with regulatory authorities (e.g., SAHPRA) on submission status and inquiries.
Review and approve promotional materials to ensure regulatory compliance.
Monitor changes in regulatory legislation and assess their impact on the company's products and operations.
Requirements
Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
Minimum of 4 years of experience in pharmaceutical regulatory affairs.
In-depth knowledge of regulatory submission processes and requirements in South Africa and key international markets.
Experience with regulatory databases and submission software.
Strong analytical, problem-solving, and communication skills.
Benefits
Competitive salary and performance-based incentives.
Comprehensive health insurance and retirement plan.
Support for professional development and regulatory training.
A collaborative work environment with opportunities for growth.
Key role in ensuring compliance and market access for pharmaceuticals in Kimberley .
#J-18808-Ljbffr