Regulatory Affairs Manager

1 month ago

Midrand, South Africa Jobted ZA C2 Full time

Overview

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: manufacturing@hireresolve.za.com

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.

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