Senior Pharmaceutical Regulatory Affairs Specialist

Placements24; Durban; On-site; ZAR 900,000 - 1,500,000; Full time

Job summary

Our client, a prominent pharmaceutical company with a strong presence in Durban, KwaZulu-Natal, seeks an experienced Senior Pharmaceutical Regulatory Affairs Specialist to oversee regulatory submissions and compliance. You will be the key liaison with authorities, guiding approvals and lifecycle management from our Durban office.

Based in Durban, you will develop regulatory strategies, review dossiers, and manage variations/renewals while ensuring alignment with local and international

Qualifications

• Minimum of 6 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA regulations and familiarity with FDA/EMA is desirable.
• Experience in preparing and submitting regulatory dossiers.

Responsibilities

• Prepare, submit, and maintain regulatory filings for NDAs, variations, and renewals per SAHPRA.
• Develop/regulatory strategies for product development and lifecycle management.
• Interpret guidelines and assess impact on operations and portfolios.

Skills

Regulatory affairs

Project management

Communication

Education

Bachelor's degree in Pharmacy

Master's degree beneficial

Tools

Regulatory information systems

Job description

About the Role

Our client, a prominent pharmaceutical company with a strong presence in Durban, KwaZulu-Natal, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to oversee and manage all aspects of regulatory submissions and compliance. This critical role ensures that our innovative pharmaceutical products meet all local and international regulatory standards before reaching the market. You will be the key point of contact for regulatory authorities, guiding product approvals and lifecycle management. This position offers a unique opportunity to shape regulatory strategies and contribute to the successful launch of new and existing medications. The Durban office is a key strategic location for our operations in the region, offering a vibrant and collaborative work environment.

Key Responsibilities

• Prepare, submit, and maintain regulatory filings for new drug applications (NDAs), variations, and renewals in compliance with SAHPRA and other relevant health authority requirements.
• Develop and implement regulatory strategies for product development and lifecycle management.
• Interpret complex regulatory guidelines and assess their impact on company operations and product portfolios.
• Act as the primary liaison with regulatory agencies, responding to queries and managing communications effectively.
• Review and approve product labeling, promotional materials, and advertising to ensure regulatory compliance.
• Conduct regulatory training for internal teams, including R&D, Marketing, and Sales.
• Monitor changes in the regulatory landscape and advise management on necessary actions.
• Manage post-approval commitments and ensure ongoing compliance of marketed products.
• Participate in due diligence activities for potential business development opportunities.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Law, or a related field.
• A Master's degree or relevant professional certification is a plus.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of South African pharmaceutical regulations (SAHPRA) and familiarity with international regulations (e.g., FDA, EMA) is highly desirable.
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Excellent understanding of drug development processes and pharmaceutical manufacturing.
• Strong analytical, strategic thinking, and problem-solving skills.
• Exceptional written and verbal communication skills, with the ability to negotiate and influence effectively.
• Proficiency in regulatory information management systems and relevant software.
• Ability to manage multiple projects simultaneously and meet tight deadlines.

Benefits

• Our client offers a competitive salary, a comprehensive benefits package including medical aid and retirement fund contributions, and opportunities for professional growth and international exposure.
• You will work within a highly professional and supportive team environment.
• We are committed to employee development and offer ongoing training.
• This role is based in our state-of-the-Durban facility.