Regulatory Affairs Manager

Hire Resolve; Midrand; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Negotiable salary

Career advancement opportunities

Job summary

A leading recruitment agency is seeking a Regulatory Affairs Manager to ensure compliance and manage product registration processes in Midrand, Gauteng. The successful candidate will lead regulatory strategies, manage documentation, and work closely with various stakeholders. A B. Pharm degree and over 10 years of experience in Regulatory Affairs are essential, along with pharmacovigilance expertise and a solid understanding of South African regulations. This position offers a negotiable salary and opportunities for career advancement.

Qualifications

• Minimum of 10 years experience in Regulatory Affairs with human medicine and biologicals.
• Competent in eCTD submissions and familiar with ZAZIBONA processes.
• Experience with product registration and dossier maintenance.
• Pharmacovigilance knowledge and SAHPRA submission familiarity.
• Proficient in eCTD submissions and ZAZIBONA processes.
• Strong MS Office skills and regulatory systems understanding.

Responsibilities

• Lead and manage the regulatory affairs processes.
• Ensure all documents comply with regulatory standards.
• Provide input on the regulatory strategy aligned with business objectives.
• Maintain dossiers, PI/PIL and QMS alignment with regulations.
• Manage internal/external audits and regulatory trainings.
• Ensure compliance with environmental and quality standards.

Skills

Regulatory documentation compliance

Pharmacovigilance experience

Knowledge of South African regulations

Microsoft Office Suite proficiency

Regulatory leadership

Education

B. Pharm (Bachelor of Pharmacy)

Registration with the South African Pharmacy Council (SAPC)

Tools

Microsoft Office

ZAZIBONA

eCTD submissions

Job description

Hire Resolve's client is actively seeking a Regulatory Affairs Manager to join their team in Midrand, Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains pharmacovigilance requirements.

Responsibilities

• Lead, manage, and execute strategic direction as the regulatory affairs manager.
• Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
• Provide input to the regulatory strategy in line with business objectives.
• Manage and implement safety updates where required.
• Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations.
• Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC)
• Write and develop SOPs in line with Global SOPs.
• Manage internal and external audits (e.g., Global & SAHPRA)
• Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
• Manage product complaints and deviations.
• Maintain regulatory documentation filing system.
• Ensure regulatory compliance and quality-related records are available and retained.
• Coordinate product recall or market withdrawal when necessary.
• Obtain and distribute updated information on domestic and international laws.
• Report ADR to Global Safety and SAHPRA and follow up on Adverse Drug Reactions (ADRs).
• Conduct pharmacovigilance training for local staff14.
• Answer requests from the Regulatory Authority in cooperation with Global Safety
• Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations.
• Identify areas for improvement within the quality system and implement corrective and preventive actions.
• Provide training to staff on quality standards, regulatory requirements, and best practices.
• Identify areas for improvement within the quality system and implement corrective measures.
• Maintain and manage quality related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
• Ensure compliance with environmental regulations and standards at local, national, and international levels.
• The manager will also manage releases of finished products, customer complaints etc.

Requirements

• B. Pharm (Bachelor of Pharmacy).
• Registration with the South African Pharmacy Council (SAPC).
• Minimum 10 years’ experience in Regulatory Affairs with human medicine and biologicals experience.
• Product registration and dossier maintenance.
• Pharmacovigilance experience and knowledge of SAHPRA submission portals.
• Launch procedures for new products.
• QA processes, APQRs, customer complaints.
• Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa.
• Microsoft Office Suite proficiency.
• Familiarity with ZAZIBONA processes and eCTD submissions
• Systems knowledge.
• Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
• Familiar with ZAZIBONA processes.
• Competent and experienced in eCTD submissions.

Benefits

Contact Hire Resolve for your next career-changing move.

• Salary: negotiable.

Apply for this role today contact Rebecca Grylls, Ashley Feldtmann, Thomas Stacey, Miné Roux at Hire Resolve or on LinkedIn

You can also visit the Hire Resolve website: hireresolve.us or email us your CV: [e-mail]

We 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.