Senior Regulatory Affairs Specialist (Pharmaceuticals)

Placements24; Polokwane; Presencial; ZAR 900.000 - 1.300.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Private health insurance

Performance bonus

Retirement savings plan

Descripción de la vacante

Placements24 in Polokwane, South Africa, seeks an experienced Senior Regulatory Affairs Specialist to lead registration strategies across global markets. You will prepare, review, and submit regulatory dossiers, and liaise with authorities to facilitate approvals.

The role requires strong analytical and communication skills with a proven CTD/ICH track record. The ideal candidate has 6+ years in regulatory affairs, depth in regulatory requirements for drug development, and the ability to drive

Formación

• Bachelor's or Master's degree in a scientific field (Pharmacy/ Chemistry/ Biology).
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting regulatory applications in key markets.
• In-depth knowledge of regulatory requirements for drug development and registration.
• Strong understanding of ICH guidelines and CTD format.
• Excellent written and verbal communication, negotiation and interpersonal skills.
• Ability to manage multiple projects and priorities under pressure.

Responsabilidades

• Prepare and submit high-quality regulatory dossiers (e.g., CTD, ANDA, NDA) for new drug applications and variations.
• Interpret and apply national and international regulatory guidelines (SAHPRA, FDA, EMA, ICH).
• Liaise with health authorities during the review process, responding to queries and requests.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Review labeling, promotional materials, and other product-related documentation for compliance.
• Manage post-approval regulatory commitments and ensure ongoing compliance.
• Conduct regulatory intelligence activities to stay abreast of evolving requirements.
• Collaborate with cross-functional teams, including R&D, quality, manufacturing, and marketing.

Conocimientos

Regulatory affairs

Global regulatory submissions

CTD/ICH knowledge

Stakeholder communication

Educación

Bachelor's or Master's degree in Pharmacy/ Chemistry/ Biology

Herramientas

Regulatory information systems

Descripción del empleo

About the Role

Our client, a prominent player in the pharmaceutical industry, is seeking an experienced Senior Regulatory Affairs Specialist to join their expanding team in Polokwane . This pivotal role requires a deep understanding of pharmaceutical regulations and a strategic approach to ensuring timely and successful registration of products in various global markets. You will be responsible for preparing, reviewing, and submitting regulatory dossiers, and liaising with health authorities to facilitate product approval. The ideal candidate possesses strong analytical skills, excellent communication abilities, and a proven track record in navigating complex regulatory landscapes. This is an outstanding opportunity to shape regulatory strategies and contribute to bringing essential medicines to patients worldwide.

Key Responsibilities

• Prepare and submit high-quality regulatory dossiers (e.g., CTD, ANDA, NDA) for new drug applications and variations.
• Interpret and apply national and international regulatory guidelines (e.g., SAHPRA, FDA, EMA, ICH).
• Liaise with health authorities during the review process, responding to queries and requests.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Review labeling, promotional materials, and other product-related documentation for compliance.
• Manage post-approval regulatory commitments and ensure ongoing compliance.
• Conduct regulatory intelligence activities to stay abreast of evolving requirements.
• Collaborate with cross-functional teams, including R&D, quality, manufacturing, and marketing.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting successful regulatory applications in key markets.
• In-depth knowledge of regulatory requirements for drug product development and registration.
• Strong understanding of ICH guidelines and common technical document (CTD) format.
• Excellent written and verbal communication, negotiation, and interpersonal skills.
• Ability to manage multiple projects, prioritize tasks, and work effectively under pressure.
• Proficiency in regulatory information management systems is a plus.

Benefits

• This position offers a highly competitive salary and a comprehensive benefits package, including private health insurance, a generous performance bonus structure, and a retirement savings plan.
• Our client is committed to employee development and provides excellent opportunities for professional growth, including specialized training and conference attendance.
• The role is based in our modern Polokwane office, offering a dynamic and collaborative work environment.
• Join a leading pharmaceutical organization dedicated to innovation and improving global health outcomes.
• We foster a culture of respect and continuous learning.