Regulatory Affairs Specialist

Placements24; Kimberley; Hybrid; CAD 50.000 - 76.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Health, dental, and retirementBenefits

Professional development opportunities

Generous leave and holidays

Zusammenfassung

Placements24 is seeking a Regulatory Affairs Specialist for a hybrid role in Kimberley. The position focuses on ensuring regulatory compliance for national and international requirements, including preparing CTD dossiers, variations, and liaising with health authorities to secure approvals.

You will guide cross-functional teams in R&D, clinical, manufacturing and marketing, monitor regulatory changes, and contribute to lifecycle strategies while ensuring adherence to labeling and promotional

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
• Master's degree or equivalent experience is an advantage.
• 3–5 years' regulatory affairs experience in pharma or medical devices.
• Strong knowledge of global regulatory requirements and submissions (FDA, EMA, SAHPRA).

Aufgaben

• Prepare and submit regulatory applications to health authorities.
• Maintain regulatory filings and ensure labeling compliance.
• Liaise with regulatory agencies to enable timely approvals.
• Provide regulatory guidance to R&D, clinical, manufacturing, and marketing.
• Monitor regulatory changes and advise on impact.
• Develop regulatory strategies for development and lifecycle management.
• Review promotional materials for regulatory compliance.
• Maintain regulatory databases and documentation systems.
• Participate in inspections and audits.
• Contribute to SOPs and training materials.

Kenntnisse

Regulatory affairs

Dossier preparation

Cross-functional collaboration

Regulatory submissions

Ausbildung

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Master's degree (advantage)

Tools

Regulatory Information Management Systems

Microsoft Office Suite

Jobbeschreibung

About the Role

Our client, a dynamic pharmaceutical company focused on developing innovative therapies, is seeking a proactive Regulatory Affairs Specialist to join their team. This role, based in Kimberley, Northern Cape, operates under a hybrid model, combining essential on-site presence with remote work flexibility. You will play a crucial role in ensuring that the company's products comply with all relevant national and international regulatory requirements. This involves preparing and submitting regulatory documentation, liaising with health authorities, and providing regulatory guidance to internal teams. The ideal candidate will possess a strong understanding of regulatory affairs processes within the pharmaceutical industry and a keen eye for detail, ensuring successful product approvals and continued market access. You will be integral to bringing vital medicines to patients, contributing to regulatory strategy from Kimberley.

Key Responsibilities

• Prepare, review, and submit regulatory applications (e.g., CTD dossiers, variations) to health authorities.
• Manage and maintain regulatory filings and ensure compliance with labeling requirements.
• Liaise effectively with regulatory agencies to facilitate timely product approvals and address inquiries.
• Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Develop and implement regulatory strategies for product development and lifecycle management.
• Review promotional materials to ensure compliance with regulatory advertising and promotion regulations.
• Maintain regulatory databases and documentation systems.
• Participate in regulatory inspections and audits.
• Contribute to the development of departmental SOPs and training materials.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• A Master's degree or equivalent experience is an advantage.
• Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
• Strong knowledge of global regulatory requirements and submission processes (e.g., FDA, EMA, SAHPRA).
• Experience with dossier preparation (e.g., CTD format) and lifecycle management.
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Strong analytical, problem-solving, and organizational skills.
• Ability to work independently and collaboratively within a hybrid team environment.
• Proficiency in regulatory information management systems and Microsoft Office Suite.
• Attention to detail and a commitment to compliance and ethical standards.

Benefits

• Competitive salary and performance-based bonus opportunities.
• Comprehensive health, dental, and retirement benefits.
• Generous annual leave allowance and paid holidays.
• Opportunities for professional development and continuing education.
• Hybrid work model promoting work-life balance.
• Supportive team environment and potential for career growth.
• Involvement in impactful projects contributing to healthcare advancements.