Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; Stellenbosch; Remote; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Performance bonuses

Job summary

Placements24 is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Specialist to join our growing team. This fully remote role allows you to work from anywhere in South Africa while managing global regulatory submissions.

You will prepare and submit CTD documents, liaise with authorities like SAHPRA, FDA, and EMA, and develop regulatory strategies to support product approvals. Strong attention to detail and clear communication are essential.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory submission requirements and processes in major markets.
• Experience preparing common technical documents (CTD) and electronic submissions.
• Familiarity with drug development lifecycle and GMP/ICH guidelines.
• Excellent analytical, organizational, and problem-solving skills.
• Strong written and verbal communication skills, with a high level of accuracy.
• Ability to work independently, manage time effectively, and meet deadlines in a remote environment.
• Experience with regulatory information management (RIM) systems is a plus.

Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals.
• Ensure all submissions comply with relevant regulations in target markets (e.g., SAHPRA, FDA, EMA).
• Liaise with regulatory authorities and respond to queries promptly and accurately.
• Maintain regulatory databases and ensure timely updates of product registrations.
• Collaborate with internal departments (e.g., R&D, Quality, Marketing) to gather necessary information for submissions.
• Monitor changes in regulatory legislation and guidelines and assess their impact.
• Provide regulatory guidance and support to project teams throughout the product lifecycle.
• Review promotional materials for regulatory compliance.
• Develop and implement regulatory strategies for product approvals.
• Effectively manage regulatory timelines and milestones in a remote setting.

Skills

Regulatory affairs

CTD submissions

GMP/ICH guidelines

Regulatory strategies

Remote work

Education

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

Tools

RIM systems

Job description

About the Role

Our client, a dynamic and growing pharmaceutical company, is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Specialist. This is a fully remote position, allowing you to work from any location within South Africa. You will be responsible for managing and preparing regulatory submissions, ensuring compliance with global regulatory requirements, and contributing to the strategic regulatory planning for our diverse product portfolio. The ideal candidate possesses a strong understanding of regulatory frameworks governing pharmaceuticals, excellent attention to detail, and superb communication skills. This role is perfect for a self-driven individual passionate about navigating the complex world of pharmaceutical regulations from the comfort of their home office.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals.
• Ensure all submissions comply with relevant regulations in target markets (e.g., SAHPRA, FDA, EMA).
• Liaise with regulatory authorities and respond to queries promptly and accurately.
• Maintain regulatory databases and ensure timely updates of product registrations.
• Collaborate with internal departments (e.g., R&D, Quality, Marketing) to gather necessary information for submissions.
• Monitor changes in regulatory legislation and guidelines and assess their impact.
• Provide regulatory guidance and support to project teams throughout the product lifecycle.
• Review promotional materials for regulatory compliance.
• Develop and implement regulatory strategies for product approvals.
• Effectively manage regulatory timelines and milestones in a remote setting.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory submission requirements and processes in major markets.
• Experience preparing common technical documents (CTD) and electronic submissions.
• Familiarity with drug development lifecycle and GMP/ICH guidelines.
• Excellent analytical, organizational, and problem-solving skills.
• Strong written and verbal communication skills, with a high level of accuracy.
• Ability to work independently, manage time effectively, and meet deadlines in a remote environment.
• Experience with regulatory information management (RIM) systems is a plus.
• Must have a dedicated home office space with reliable internet connectivity.

Benefits

• This fully remote position offers a competitive salary and a comprehensive benefits package, including health insurance, retirement contributions, and performance bonuses.
• Our client is committed to professional development, providing opportunities for training and career advancement.
• Enjoy the flexibility and autonomy of working remotely while being a key contributor to a reputable pharmaceutical organization’s success.
• Join our collaborative team and help bring life-changing medicines to patients worldwide.