Regulatory Affairs Specialist

Placements24; East End (United States Virgin Islands); Hybrid; USD 42,000 - 66,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Retirement fund contributions

Professional development opportunities

Hybrid work model

Job summary

Placements24 is seeking a Regulatory Affairs Specialist to ensure compliance for pharmaceutical products in South Africa. You will prepare and submit regulatory dossiers, liaise with health authorities, and stay updated on SAHPRA and ICH guidelines. The role supports product registrations and market access.

You will work in a dynamic team with a hybrid work model, managing multiple projects with strict deadlines while ensuring accurate labeling and promotional adherence.

Qualifications

• 3–5 years of regulatory affairs experience in pharma/biotech.
• Knowledge of SAHPRA regulations and international guidelines (ICH).
• Strong communication and project multitasking skills.

Responsibilities

• Prepare, review, and submit regulatory dossiers to national authorities.
• Monitor regulatory guidelines and advise development teams.
• Interact with regulatory agencies, respond to queries, and support inspections.
• Ensure lifecycle compliance, including labeling and promotion rules.
• Develop regulatory strategies to enable product registration and market access.

Skills

Regulatory affairs

Project management

Attention to detail

Excellent communication

Education

Bachelor's or Master's degree in Pharmacy or Life Sciences

Job description

About the Role

Our client is looking for a skilled Regulatory Affairs Specialist to ensure compliance with all regulatory requirements for their pharmaceutical products in Welkom . This role is essential for navigating the complex landscape of national and international health regulations, facilitating the smooth and timely approval of new drugs and medical devices. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes. Your expertise will be crucial in bringing innovative treatments to market efficiently and safely, supporting the company's mission in the Free State region and beyond.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations) to national health authorities.
• Monitor and interpret new and existing regulatory guidelines and provide strategic advice to product development teams.
• Liaise with regulatory agencies, respond to queries, and facilitate inspections and audits.
• Maintain regulatory compliance throughout the product lifecycle, ensuring adherence to labeling and promotional requirements.
• Develop and implement regulatory strategies to support product registration and market access.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
• 3-5 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• In-depth knowledge of South African regulatory requirements (SAHPRA) and international guidelines (e.g., ICH).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to manage multiple projects simultaneously and meet strict deadlines.

Benefits

• Competitive salary and performance incentives.
• Comprehensive medical aid and retirement fund contributions.
• Professional development opportunities and training in regulatory affairs.
• Hybrid work model offering flexibility between office and remote work.
• Dynamic work environment with opportunities to contribute to significant product launches.