Remote Pharmaceutical Regulatory Affairs Specialist

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

Benefits offered by this job

Competitive salary

Bonus potential

Health insurance

Retirement plan

Paid time off

Home office allowance

Professional development

Remote autonomy

Job summary

Placements24, a global pharmaceutical company, seeks a Remote Pharmaceutical Regulatory Affairs Specialist to prepare, review, and submit regulatory filings worldwide and maintain ongoing compliance with evolving global regulations.

You will liaise with health authorities (FDA/EMA/SAHPRA) and collaborate with R&D, quality, and legal teams to enable timely product approvals and continued market access in a fully remote setting.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences.
• Minimum 5 years in pharmaceutical regulatory affairs.
• Strong knowledge of FDA/EMA/SAHPRA guidelines.
• Experience preparing and submitting regulatory dossiers.
• GMP/GCP/GLP understanding.
• Excellent written and verbal communication.
• Ability to work independently in a remote setting.
• Proficiency with regulatory information management systems (RIMS) is a plus.

Responsibilities

• Prepare and submit regulatory documents (INDs, NDAs, MAAs) to health authorities.
• Ensure product and process compliance with global regulations.
• Monitor regulatory changes and advise internal teams.
• Act as primary contact for authorities during submissions.
• Develop regulatory strategies for development, registration, lifecycle.
• Review promotional materials for regulatory compliance.
• Manage post-approval activities: amendments, annual reports, renewals.
• Conduct regulatory intelligence to identify risks and opportunities.
• Coordinate with R&D, QA, and manufacturing to integrate requirements.
• Maintain regulatory databases and documentation systems.

Skills

Regulatory affairs expertise

Regulatory strategy communication

Attention to detail

Time management

Independent work

Education

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

Tools

RIMS

Job description

About the Role Our client, a globally recognized pharmaceutical company at the forefront of medical innovation, is seeking a highly skilled and dedicated Remote Pharmaceutical Regulatory Affairs Specialist. This role is essential for ensuring that the company's products meet all regulatory requirements for marketing and distribution worldwide. As a fully remote position, you will be responsible for preparing, reviewing, and submitting regulatory filings, maintaining compliance with evolving global regulations, and liaising with health authorities. You will work collaboratively with internal teams, including R&D, quality, and legal, as well as external partners, to navigate the complex regulatory landscape. We are looking for an experienced regulatory professional who is adept at interpreting guidelines and can effectively communicate regulatory strategies to ensure timely product approvals and continued market access. This is an excellent opportunity to make a significant impact from a remote setting.

Key Responsibilities

• Prepare, review, and compile high-quality regulatory submission documents (e.g., INDs, NDAs, MAAs, variations) for various health authorities globally.
• Ensure compliance of company products and processes with relevant national and international pharmaceutical regulations.
• Monitor and assess changes in the regulatory landscape, providing strategic guidance to internal stakeholders.
• Serve as the primary point of contact for regulatory agencies during the submission and review process.
• Develop and implement regulatory strategies to support product development, registration, and lifecycle management.
• Review promotional materials, labeling, and other product-related documents for regulatory compliance.
• Manage post-approval regulatory activities, including amendments, annual reports, and renewals.
• Conduct regulatory intelligence activities to identify opportunities and potential risks.
• Collaborate with R&D, Quality Assurance, and Manufacturing to ensure regulatory requirements are integrated into product development and lifecycle management.
• Maintain regulatory databases and documentation systems.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, SAHPRA) and guidelines for drug development and marketing.
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Strong understanding of GMP, GCP, and GLP principles.
• Excellent written and verbal communication skills, with exceptional attention to detail.
• Strong analytical and problem-solving abilities.
• Ability to work independently, manage multiple projects, and meet tight deadlines in a remote environment.
• Proficiency in regulatory information management systems (RIMS) is a plus.

Benefits

• Highly competitive salary and potential for performance bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous retirement savings plan with employer contributions.
• Substantial paid time off and company holidays.
• Home office technology allowance and support.
• Opportunities for continuous professional development, including webinars, conferences, and certifications.
• The flexibility and autonomy afforded by a fully remote work model, promoting work-life balance.