Regulatory Affairs Specialist - Pharmaceuticals

Placements24; The Islands (MS); On-site; USD 43,000 - 55,000; Full time

Benefits offered by this job

Salary with potential bonuses

Health and wellness benefits

Growth and specialization in Paarl

Collaborative, compliant work culture

Job summary

Placements24 is seeking a meticulous Regulatory Affairs Specialist to join the team in Paarl. The role involves preparing regulatory dossiers, ensuring compliance, and liaising with health authorities to support timely product approvals and market access.

You will work with R&D, manufacturing, and marketing to provide regulatory input. The ideal candidate has a Bachelor's degree in a related field and at least 4 years of regulatory affairs experience, with strong written and verbal communication

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 4+ years of Regulatory Affairs experience in pharma industry.
• Strong knowledge of regulatory pathways and submission requirements.
• Experience with electronic submission tools and databases.

Responsibilities

• Prepare, compile, and submit regulatory dossiers (CTD, NDA, ANDA) to authorities.
• Maintain up-to-date knowledge of global regulatory requirements.
• Manage post-approval activities: variations, renewals, reports.
• Liaise with regulatory agencies and support cross-functional teams.

Skills

Regulatory knowledge

Dossier preparation

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Tools

Electronic submission tools

Regulatory databases

EDMS/Document management

Job description

About the Role

Our client is seeking a meticulous and knowledgeable Regulatory Affairs Specialist to join their team in Paarl. This position is crucial for navigating the complex regulatory landscape and ensuring that the company's pharmaceutical products meet all required standards for approval and marketing. You will be responsible for preparing and submitting regulatory dossiers, maintaining compliance, and liaising with health authorities. This is an excellent opportunity to contribute to global health by ensuring timely access to safe and effective medicines, working within a collaborative and expert team.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to health authorities.
• Maintain up-to-date knowledge of global regulatory requirements and guidelines for pharmaceutical products.
• Manage post-approval regulatory activities, including variations, renewals, and annual reports.
• Serve as a key liaison between the company and regulatory agencies.
• Provide regulatory input and support to cross-functional teams, including R&D, manufacturing, and marketing.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 4 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Thorough understanding of pharmaceutical regulatory pathways and submission requirements in key markets.
• Experience with electronic submission tools and databases.
• Excellent written and verbal communication skills, with strong attention to detail and organizational abilities.

Benefits

• Competitive annual salary and potential for bonuses.
• Comprehensive health and wellness benefits package.
• Opportunities for professional growth and specialization in Paarl.
• Exposure to a wide range of pharmaceutical products and regulatory challenges.
• A dynamic and supportive work environment focused on compliance and innovation.