Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; Bloemfontein; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Retirement fund

Hybrid work model

Professional development

Public health impact

Job summary

Placements24 is partnering with a respected pharmaceutical company in Bloemfontein, Free State, to appoint a meticulous Regulatory Affairs Specialist in a hybrid role blending remote work with on-site collaboration.

You will prepare, submit, and manage regulatory dossiers with SAHPRA, FDA, and EMA, liaising with health authorities and internal teams to ensure compliant submissions and timely approvals.

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or related field.
• Minimum of 3 years of experience in pharma regulatory affairs.
• Experience preparing and submitting regulatory dossiers.
• Solid knowledge of SAHPRA, FDA, and EMA requirements.
• Excellent written and verbal communication.
• Strong attention to detail and organization.
• Proficiency in regulatory submission software and MS Office.
• Ability to work in a hybrid team and independently.
• Proactive approach to identifying regulatory challenges.

Responsibilities

• Prepare, review, and submit regulatory dossiers to health authorities (SAHPRA, FDA, EMA).
• Ensure submissions are accurate, complete, and compliant with guidelines.
• Maintain regulatory databases and tracking systems for submissions and approvals.
• Liaise with health authorities to respond to queries with required information.
• Monitor regulatory changes and assess impact on operations.
• Collaborate with R&D, manufacturing, and QA for submission data.
• Provide regulatory guidance to project teams during product lifecycle.
• Manage post-approval activities including variations and annual reports.
• Contribute to development and implementation of regulatory strategies.

Skills

Regulatory submissions

Pharma regulations

Documentation accuracy

Cross-functional collaboration

Communication

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Regulatory software

Microsoft Office

Job description

About the Role

Our client, a respected pharmaceutical company, is looking for a meticulous Regulatory Affairs Specialist to join their team in Bloemfontein, Free State. This hybrid role combines the flexibility of remote work with the necessity of on-site collaboration and regulatory interactions. You will be responsible for preparing, submitting, and managing regulatory documentation for pharmaceutical products, ensuring compliance with national and international health authority requirements. This position offers an excellent opportunity to contribute to bringing new and essential medicines to market. The ideal candidate will have a strong grasp of regulatory frameworks and a keen eye for detail in documentation. You will work closely with various departments to ensure smooth and timely regulatory approvals, playing a crucial part in the company's success and its mission to improve healthcare access. Your contribution will be vital in navigating complex regulatory landscapes.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities such as SAHPRA, FDA, and EMA.
• Ensure all regulatory submissions are accurate, complete, and compliant with current guidelines.
• Maintain regulatory databases and tracking systems for submissions and approvals.
• Liaise with health authorities to respond to queries and provide additional information as required.
• Monitor changes in regulatory legislation and guidance and assess their impact on company operations.
• Collaborate with R&D, manufacturing, and quality assurance departments to gather necessary information for submissions.
• Provide regulatory guidance and support to project teams throughout the product lifecycle.
• Manage post-approval regulatory activities, including variations and annual reports.
• Contribute to the development and implementation of regulatory strategies.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting regulatory dossiers.
• Solid understanding of SAHPRA, FDA, and EMA regulatory requirements and guidelines.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Proficiency in regulatory submission software and Microsoft Office Suite.
• Ability to work effectively both independently and as part of a hybrid team.
• Proactive approach to identifying and resolving regulatory challenges.

Benefits

• Competitive salary and potential for annual bonus.
• Comprehensive medical aid and retirement fund benefits.
• Generous annual leave allowance.
• Hybrid work model offering a balance between remote and office-based work.
• Opportunities for professional development and training.
• Be part of a company dedicated to improving public health.