Senior Regulatory Affairs Manager - Pharma (Hybrid)

Placements24; Richards Bay; Hybrid; ZAR 900.000 - 1.200.000; Vollzeit

Benefits dieser Stelle

Health insurance

Professional development

Hybrid work model

Performance incentives

Zusammenfassung

Placements24 is seeking a Pharmaceutical Regulatory Affairs Manager in Richards Bay to lead regulatory strategies, submissions, and interactions with health authorities. This hybrid role requires strategic thinking and meticulous attention to detail to ensure market authorization and lifecycle compliance.

You will collaborate with R&D, manufacturing, and marketing to align regulatory plans with business objectives, monitor global changes, and guide cross-functional teams through CTD submissions

Qualifikationen

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences or related field.
• Minimum 5 years of pharmaceutical regulatory affairs experience.
• Proven experience preparing and submitting marketing authorization applications.
• Deep knowledge of global regulatory requirements and submission processes.
• Strong strategic thinking, analytical and communication skills.
• Ability to manage multiple projects in a cross-functional team environment.

Aufgaben

• Develop and implement regulatory strategies for product registration and lifecycle management across markets.
• Prepare, review, and submit regulatory dossiers (CTD format) to health authorities.
• Serve as primary contact with regulatory agencies, responding to queries and managing submissions.
• Ensure compliance with local and international pharmaceutical regulations and standards.
• Provide regulatory input to R&D, manufacturing, marketing and other departments.
• Monitor regulatory changes and assess impact on products and operations.

Kenntnisse

Regulatory strategy

Dossier submission

Regulatory liaison

Cross-functional collaboration

Pharmaceutical regulations

Strategic thinking

Ausbildung

Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences

Tools

CTD format

Jobbeschreibung

Placements24 is seeking a Pharmaceutical Regulatory Affairs Manager in Richards Bay to lead regulatory strategies, submissions, and interactions with health authorities. This hybrid role requires strategic thinking and meticulous attention to detail to ensure market authorization and lifecycle compliance.

You will collaborate with R&D, manufacturing, and marketing to align regulatory plans with business objectives, monitor global changes, and guide cross-functional teams through CTD submissions