Senior Regulatory Affairs Specialist (Pharmaceuticals)

Placements24; Richards Bay; Sur place; ZAR 900 000 - 1 500 000; Plein temps

Avantages offerts par ce poste

Performance bonus

Medical benefits

Retirement benefits

International travel

Résumé du poste

Placements24 is seeking a Senior Regulatory Affairs Specialist to oversee regulatory submissions and compliance for a diverse product portfolio. Based in Richards Bay, KwaZulu-Natal, you will navigate global regulatory landscapes to ensure market approvals and ongoing compliance.

You will lead dossier preparation for SAHPRA, FDA, and EMA, advise on development strategies, and collaborate with R&D, Manufacturing, and Marketing to align regulatory plans. On-site role with competitive benefits.

Qualifications

• Bachelor's degree in a scientific or pharmaceutical discipline; advanced degree preferred.
• Minimum of 6 years in pharmaceutical regulatory affairs.
• Experience with SAHPRA, FDA, EMA submissions.
• Strong communication and negotiation abilities.
• Ability to manage multiple projects in a fast-paced environment.

Responsabilités

• Prepare, review, and submit regulatory dossiers to health authorities (SAHPRA, FDA, EMA).
• Ensure product labeling and promotional materials comply with regulatory requirements.
• Maintain regulatory compliance for approved products throughout their lifecycle.
• Provide strategic regulatory guidance on development and lifecycle management.
• Liaise with regulatory agencies and respond to queries.
• Monitor regulatory changes and advise on impact.
• Support post-approval changes, variations, and renewals.
• Collaborate with R&D, Manufacturing, Marketing to align regulatory plans.
• Develop and implement regulatory processes and training programs.
• Manage regulatory databases and documentation.

Connaissances

Communication

Negotiation

Analytical thinking

Project management

Independent work

Formation

Bachelor's degree in science or pharmacy

Outils

Regulatory information systems

CTD submissions

Description du poste

About the Role

A prominent pharmaceutical company is seeking an experienced Senior Regulatory Affairs Specialist to oversee and manage regulatory submissions and compliance activities for their product portfolio. This critical role, based in Richards Bay, KwaZulu-Natal, requires a deep understanding of global regulatory landscapes and a proven ability to navigate complex compliance requirements. The specialist will play a key role in ensuring that products meet all necessary standards for market approval and continued compliance. This position is ideal for a seasoned professional looking to make a significant impact in a challenging and rewarding environment. You will be a key player in bringing vital medicines to patients worldwide.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers to health authorities (e.g., SAHPRA, FDA, EMA).
• Ensure all product labeling and promotional materials comply with regulatory requirements.
• Maintain regulatory compliance for approved products throughout their lifecycle.
• Provide strategic regulatory guidance on product development, lifecycle management, and global submission strategies.
• Liaise with regulatory agencies, responding to queries and facilitating communication.
• Monitor and assess changes in the regulatory environment and advise the company accordingly.
• Support post-approval changes, variations, and renewals of product registrations.
• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Marketing) to ensure regulatory alignment.
• Develop and implement regulatory processes and training programs.
• Manage and maintain regulatory databases and documentation.

Requirements

• Bachelor's degree in a scientific, pharmaceutical, or related discipline; advanced degree preferred.
• Minimum of 6 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory requirements in key markets (South Africa, Europe, USA).
• Proven experience in preparing and submitting various types of regulatory dossiers (e.g., CTD).
• Strong understanding of pharmaceutical product development and manufacturing.
• Excellent written and verbal communication skills, with strong negotiation abilities.
• Proficiency in regulatory information management systems.
• Ability to work independently and manage multiple projects in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Must be willing to work on-site in Richards Bay, KwaZulu-Natal.

Benefits

This role comes with a highly competitive salary, a performance bonus, comprehensive medical and retirement benefits, and opportunities for professional development and international travel. We offer a supportive work environment in Richards Bay, KwaZulu-Natal, where your expertise is valued. Join a company committed to ethical practices and scientific advancement, contributing to global health outcomes.