Senior Pharmaceutical Regulatory Affairs Specialist

Placements24; Klerksdorp; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Remote-first work environment

Home office stipend

Professional development support

Flexible working hours

Job summary

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join a remote-based team. You will manage regulatory submissions, interact with health authorities, and provide strategic regulatory guidance across lifecycle stages from anywhere in South Africa.

The role requires extensive knowledge of FDA/EMA/ICH guidelines, 7+ years of experience, and the ability to work independently in a fast-paced, global environment.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related life science.
• Minimum 7 years' experience in pharmaceutical regulatory affairs.
• Experience with global regulatory requirements and submissions (FDA, EMA, ICH).
• Able to work remotely and manage multiple complex projects.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD/IND/NDA) to health authorities worldwide.
• Interpret and apply global regulatory guidelines to product development and lifecycle management.
• Serve as primary point of contact for health authorities on assigned projects.
• Develop and implement regulatory strategies to support development, registration, and lifecycle maintenance.
• Provide regulatory guidance to cross-functional teams (R&D, clinical, manufacturing, marketing).
• Manage post-approval activities such as variations, renewals, and annual reports.
• Review promotional materials for regulatory compliance and participate in inspections/audits.

Skills

Regulatory strategy

Regulatory submissions

Health authority interactions

Regulatory intelligence

Remote project management

Education

Bachelor's degree in Pharmacy/related life science

Master's degree preferred

Job description

About the Role

Our client, a globally recognized pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their remote-based team. This critical role involves ensuring that our pharmaceutical products comply with all relevant national and international regulatory requirements throughout their lifecycle. As a fully remote position, you will leverage your expertise to manage regulatory submissions, interact with health authorities, and provide strategic regulatory guidance to internal teams. This role demands a thorough understanding of regulatory frameworks, submission processes, and compliance strategies within the pharmaceutical industry. You will be instrumental in navigating the complex regulatory landscape, facilitating the timely approval and market access of our innovative medicines. This is an exceptional opportunity for a seasoned regulatory professional to make a significant impact from anywhere in **South Africa**, contributing to global health initiatives while enjoying the flexibility of a remote-first work environment. The company fosters a culture of collaboration and excellence, supported by advanced digital communication tools. Your deep knowledge of regulatory affairs will be essential for the success of our product portfolio. This is a key position within our regulatory affairs department, requiring meticulous attention to detail and strategic thinking.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
• Interpret and apply global regulatory guidelines and requirements to product development and lifecycle management.
• Serve as the primary point of contact for health authorities on assigned projects.
• Develop and implement regulatory strategies to support product development, registration, and lifecycle maintenance.
• Conduct regulatory intelligence activities to stay abreast of evolving regulations and competitor strategies.
• Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
• Manage post-approval regulatory activities, such as variations, renewals, and annual reports.
• Review and approve promotional and advertising materials to ensure regulatory compliance.
• Participate in regulatory inspections and audits.
• Contribute to the development and improvement of regulatory processes and systems.
• Assess the regulatory impact of manufacturing changes or product lifecycle events.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline; Master's degree or equivalent is preferred.
• Minimum of 7 years of experience in pharmaceutical regulatory affairs.
• Extensive knowledge of global regulatory requirements and submission guidelines (e.g., FDA, EMA, ICH).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Demonstrated ability to develop and execute effective regulatory strategies.
• Strong understanding of drug development processes and pharmaceutical manufacturing.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with a strong command of scientific and regulatory language.
• Proven ability to work independently and manage multiple complex projects in a remote setting.
• Experience in managing interactions with health authorities.
• Detail-oriented with a high degree of accuracy.
• Must be located within **South Africa** to adhere to any local regulatory nuances or communication needs, even though the role is fully remote.

Benefits

• Our client offers a highly competitive salary and benefits package for this fully remote role.
• This includes comprehensive health, dental, and vision insurance.
• A generous retirement savings plan with employer contributions is provided.
• Significant paid time off, including vacation, sick leave, and holidays.
• Opportunities for professional development, including training, conferences, and certifications, are fully supported.
• This remote position offers unparalleled flexibility and eliminates commuting time and costs.
• A home office stipend is provided to ensure a productive work environment.
• Performance-based bonuses are awarded for outstanding contributions.
• Access to cutting-edge regulatory intelligence tools.
• A culture that promotes work-life balance and employee well-being.
• Potential for career advancement within a leading global pharmaceutical organization.
• Exposure to a diverse portfolio of innovative products.