Regulatory Affairs Specialist

Placements24; Bloemfontein; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Remote work

Flexible hours

Professional development opportunities

Comprehensive benefits package

Job summary

Placements24 is seeking a knowledgeable Regulatory Affairs Specialist to manage regulatory strategies for pharmaceutical products in a fully remote role across South Africa.

You will prepare submission dossiers, liaise with SAHPRA, ensure ongoing compliance, and advise R&D, marketing and manufacturing teams from home. This position offers flexible hours, professional development opportunities, and a comprehensive benefits package.

Qualifications

• 3+ years of regulatory affairs experience in the pharmaceutical industry.
• Strong knowledge of SAHPRA submission processes.
• Excellent analytical, problem-solving and project management skills.
• Clear written and verbal communication; able to work remotely.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for product registration and variations (e.g., SAHPRA).
• Ensure ongoing compliance of approved products with local and international requirements.
• Serve as liaison between the company and regulatory agencies; respond to queries.
• Monitor regulatory changes and assess impact on products and strategies.
• Provide regulatory guidance to R&D, marketing and manufacturing teams.
• Review promotional materials and product labeling for compliance.

Skills

Regulatory affairs

Dossier preparation

SAHPRA submissions

Education

Degree in Pharmacy, Law, Science or related field

Job description

About the Role

Our client seeks a knowledgeable and proactive Regulatory Affairs Specialist to manage and execute regulatory strategies for their pharmaceutical products. This fully remote position allows you to work from anywhere within South Africa , focusing on navigating the complex regulatory landscape to ensure timely approval and compliance of new and existing products. You will be responsible for preparing submission dossiers, communicating with regulatory agencies, and staying abreast of evolving regulations. This is an ideal opportunity for an experienced regulatory professional who thrives in an independent, home-based work environment and is passionate about facilitating patient access to vital medicines.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for product registration and variations to regulatory authorities (e.g., SAHPRA).
• Ensure ongoing compliance of approved products with local and international regulatory requirements.
• Serve as a key liaison between the company and regulatory agencies, responding to queries and facilitating communication.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Provide regulatory guidance and support to internal teams, including R&D, marketing, and manufacturing.
• Review promotional materials and product labeling for regulatory compliance.

Requirements

• Degree in Pharmacy, Law, Science, or a related field.
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of South African pharmaceutical regulations and submission processes.
• Proven experience in preparing and submitting registration applications.
• Excellent analytical, problem-solving, and project management skills.
• Strong written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Ability to work independently and manage deadlines effectively in a remote setting .

Benefits

• Competitive annual salary commensurate with experience.
• Comprehensive health and retirement benefits package.
• Flexible working hours and a fully remote work arrangement.
• Professional development opportunities, including regulatory training and conferences.
• Opportunity to shape the regulatory strategy for innovative pharmaceutical products.