Pharmaceutical Regulatory Affairs Specialist

Placements24; Pietermaritzburg; Hybride; ZAR 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement savings

Performance incentives

Training & conferences

Hybrid work model

Résumé du poste

Placements24 is seeking a Pharmaceutical Regulatory Affairs Specialist in Pietermaritzburg, KwaZulu-Natal. You will ensure SAHPRA and global regulatory compliance, prepare dossiers, liaise with authorities, and manage post‑market activities in a hybrid role.

The ideal candidate holds a relevant science degree, 5+ years in regulatory affairs, CTD experience, and strong communication and project management skills to drive submissions and lifecycle plans.

Qualifications

• Minimum of 5 years of experience in pharmaceutical regulatory affairs, with a proven track record of submissions and registrations.
• In-depth knowledge of pharmaceutical regulations in key markets, particularly South Africa.
• Experience in preparing and compiling CTD modules.
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly.

Responsabilités

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals in accordance with regional and global requirements (e.g., SAHPRA, FDA, EMA).
• Serve as the primary point of contact with regulatory health authorities, responding to queries and facilitating communication.
• Monitor and analyze regulatory trends, guidelines, and legislation impacting the pharmaceutical industry and our client's product portfolio.
• Ensure compliance of marketing materials, labeling, and advertising with regulatory standards.
• Conduct regulatory intelligence activities to identify emerging requirements and provide strategic input for product development and lifecycle management.
• Collaborate with cross-functional teams, including R&D, Clinical Affairs, Marketing, and Legal, to ensure regulatory requirements are met throughout product development.
• Manage post-approval regulatory activities, including annual reports, pharmacovigilance reporting, and compliance updates.
• Maintain regulatory databases and filing systems, ensuring accuracy and completeness of all regulatory information.
• Participate in internal and external audits related to regulatory compliance.

Connaissances

Regulatory affairs

CTD modules

Regulatory intelligence

Cross-functional collaboration

Attention to detail

Formation

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field

Outils

RIM systems

Microsoft Office Suite

Description du poste

About the Role

Our client, a globally recognized pharmaceutical company committed to developing innovative therapies, is seeking a highly competent Pharmaceutical Regulatory Affairs Specialist to join their team in **Pietermaritzburg, KwaZulu-Natal**. This critical role involves ensuring that all company products comply with relevant national and international regulatory requirements, from initial submission through to post-market surveillance. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes. The ideal candidate possesses a strong understanding of pharmaceutical regulations, excellent analytical and communication skills, and the ability to manage complex projects within tight deadlines. This hybrid role combines essential in-office collaboration with flexible remote work, offering a dynamic work experience.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals in accordance with regional and global requirements (e.g., SAHPRA, FDA, EMA).
• Serve as the primary point of contact with regulatory health authorities, responding to queries and facilitating communication.
• Monitor and analyze regulatory trends, guidelines, and legislation impacting the pharmaceutical industry and our client's product portfolio.
• Ensure compliance of marketing materials, labeling, and advertising with regulatory standards.
• Conduct regulatory intelligence activities to identify emerging requirements and provide strategic input for product development and lifecycle management.
• Collaborate with cross-functional teams, including R&D, Clinical Affairs, Marketing, and Legal, to ensure regulatory requirements are met throughout product development.
• Manage post-approval regulatory activities, including annual reports, pharmacovigilance reporting, and compliance updates.
• Maintain regulatory databases and filing systems, ensuring accuracy and completeness of all regulatory information.
• Participate in internal and external audits related to regulatory compliance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field. A Master's degree or relevant professional certification is a strong asset.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs, with a proven track record of successful submissions and registrations.
• In-depth knowledge of pharmaceutical regulations in key markets, particularly South Africa.
• Experience in preparing and compiling Common Technical Document (CTD) modules.
• Strong understanding of drug development processes, manufacturing, and quality assurance.
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Exceptional organizational skills and meticulous attention to detail.
• Proficiency in regulatory information management (RIM) systems and Microsoft Office Suite.
• Ability to work effectively in a hybrid environment, balancing independent work with team collaboration.
• Residing in or willing to commute to **Pietermaritzburg, KwaZulu-Natal** for required in-office collaboration.

Benefits

• Our client offers a competitive compensation package, including a comprehensive benefits plan with health insurance, retirement savings, and performance incentives.
• We provide opportunities for professional growth and development, including training and conference attendance.
• The hybrid work model is designed to support work-life balance.
• This role is located in **Pietermaritzburg, KwaZulu-Natal**.