Senior Regulatory Affairs Specialist

Placements24; Kimberley; Híbrido; CAD 76 000 - 127 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Private medical insurance

Retirement fund

Incentives based on performance

Training and industry conferences

Hybrid work model

Resumo da oferta

Placements24 is seeking a Senior Regulatory Affairs Specialist for a hybrid role in Kimberley. The candidate will lead regulatory submissions, craft strategies for product registrations, and coordinate with SAHPRA, FDA, and EMA to secure approvals across multiple markets.

The role requires a strong background in regulatory affairs, excellent analytical skills, and the ability to work across R&D, manufacturing, and marketing teams in a dynamic environment.

Qualificações

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related life science field.
• Advanced degree preferred.
• Minimum 7 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of global regulatory submission requirements and processes (e.g., CTD).
• Experience preparing and submitting dossiers to major health authorities.

Responsabilidades

• Prepare, review, and submit regulatory dossiers (CTD, ANDA, NDS) to health authorities.
• Develop regulatory strategies for new product registrations and post-approval changes.
• Liaise with regulatory agencies (SAHPRA, FDA, EMA) to address queries and facilitate approvals.
• Monitor evolving regulatory guidelines and advise internal teams.
• Ensure compliance with regulations across manufacturing, labeling, and advertising.
• Manage post-approval regulatory activities (variations, renewals, annual reports).
• Conduct regulatory intelligence to stay informed on global trends.
• Provide regulatory support to R&D, manufacturing, and marketing.

Conhecimentos

Regulatory affairs

Dossier submission

Regulatory strategy

Cross-functional collaboration

Formação académica

Bachelor's in life science

Advanced degree preferred

Ferramentas

Regulatory databases

Submission software

Descrição da oferta de emprego

About the Role

Our client, a dynamic and expanding pharmaceutical company, is actively seeking a highly experienced Senior Regulatory Affairs Specialist to join their dedicated team in Kimberley, Northern Cape. This pivotal role involves ensuring that our pharmaceutical products comply with all relevant national and international regulatory requirements throughout their lifecycle. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance to product development teams. The ideal candidate possesses a deep understanding of regulatory affairs principles, excellent analytical skills, and a proven ability to navigate complex regulatory landscapes. This position is based at our client's modern offices in Kimberley, offering a hybrid work arrangement that combines on-site collaboration with the flexibility of remote work. We are looking for a proactive and detail-oriented professional who can contribute to the successful registration and market access of our innovative medicines.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDS) to health authorities in various markets.
• Develop regulatory strategies for new product registrations and post-approval changes.
• Liaise directly with regulatory agencies (e.g., SAHPRA, FDA, EMA) to address queries and facilitate approvals.
• Monitor and interpret evolving regulatory guidelines and advise internal teams accordingly.
• Ensure compliance with all applicable regulations, including manufacturing, labeling, and advertising.
• Manage post-approval regulatory activities, such as variations, renewals, and annual reports.
• Conduct regulatory intelligence activities to stay informed about global regulatory trends.
• Provide regulatory support and guidance to cross-functional teams, including R&D, manufacturing, and marketing.
• Maintain accurate regulatory documentation and databases.
• Participate in audits and inspections as the regulatory representative.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Advanced degree preferred.
• Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of global regulatory submission requirements and processes (e.g., CTD format).
• Experience in preparing and submitting dossiers to major health authorities.
• Strong understanding of pharmaceutical product development, manufacturing, and quality assurance.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, with strong attention to detail.
• Ability to work effectively in a hybrid environment and manage multiple projects simultaneously.
• Proactive and able to work independently with minimal supervision.
• Familiarity with regulatory submission software and databases.

Benefits

• Competitive salary commensurate with experience
• Private medical insurance
• A generous retirement fund
• Performance-based incentives
• Continuous learning opportunities, including access to specialized training, workshops, and industry conferences
• Hybrid work model provides flexibility while ensuring essential collaboration