Senior Regulatory Affairs Specialist

Placements24; Sandton; Hybride; ZAR 900 000 - 1 400 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement fund

Performance bonuses

Résumé du poste

Placements24 is seeking a Senior Regulatory Affairs Specialist for a hybrid role in Sandton, Gauteng. You will navigate SAHPRA, FDA, and EMA requirements, lead regulatory submissions, and advise cross-functional teams on compliance across lifecycle stages.

Ideal candidates have 5+ years in regulatory affairs, strong analytical skills, and experience managing complex submissions in global markets. Hybrid work offers flexibility with in-office collaboration.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting regulatory submissions for various product types.

Responsabilités

• Prepare, review, and submit regulatory dossiers (CTD, ANDA, NDA) to health authorities.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Liaise with regulatory agencies (SAHPRA, FDA, EMA) and respond to queries.
• Ensure compliance with applicable regulations, guidelines, and standards for pharmaceutical products.
• Monitor changes in the regulatory landscape and assess their impact on products and operations.
• Provide regulatory guidance to cross-functional teams (R&D, manufacturing, marketing).
• Review promotional materials and labeling for regulatory compliance.
• Manage post-approval changes and variations.
• Participate in regulatory inspections and audits.

Connaissances

Regulatory affairs expertise

Regulatory strategy

Dossier preparation & submission

Cross-functional collaboration

Formation

Bachelor's or Master's degree in Pharmacy/related field

Outils

Regulatory information management systems

Description du poste

About the Role

Our client, a prominent pharmaceutical company known for its commitment to innovation and quality, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their team. This role will be based in a hybrid model, offering a blend of remote flexibility and in-office collaboration in Sandton, Gauteng . You will be responsible for ensuring that our client's pharmaceutical products comply with all relevant national and international regulatory requirements throughout their lifecycle. This includes preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance. The ideal candidate will possess a deep understanding of regulatory frameworks, strong analytical skills, and a proven ability to navigate complex regulatory landscapes.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Liaise with regulatory agencies (e.g., SAHPRA, FDA, EMA) and respond to queries.
• Ensure compliance with all applicable regulations, guidelines, and standards for pharmaceutical products.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Review promotional materials and labeling to ensure regulatory compliance.
• Manage post-approval changes and variations.
• Participate in regulatory inspections and audits.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting regulatory submissions for various product types.
• In-depth knowledge of regulatory requirements in key markets (South Africa, US, Europe).
• Excellent understanding of the drug development process and pharmaceutical manufacturing.
• Strong analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication and presentation skills.
• Ability to work effectively in a team environment and manage multiple projects simultaneously.
• Experience with regulatory information management systems is a plus.
• Willingness to work a hybrid schedule in Sandton, Gauteng.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health insurance, performance bonuses, and a retirement fund. We invest in our employees' professional development through training programs, conference attendance, and opportunities for career advancement. The hybrid work model provides flexibility while maintaining essential in-person collaboration. Join a dynamic regulatory affairs department and contribute to bringing safe and effective medicines to patients.