Senior Regulatory Affairs Specialist

Placements24; Stellenbosch; Hybrid; ZAR 2,300,000 - 3,122,000; Full time

Benefits offered by this job

Fully remote work arrangement with Aut

Highly competitive annual salary and a

Comprehensive executive-level health &

Generous vacation policy and travel

Professional development budget

Dynamic and forward-thinking culture

Job summary

Placements24 is seeking a highly experienced Senior Regulatory Affairs Specialist to lead regulatory strategies for global pharma programs. This fully remote role offers strategic influence across markets and a path to shape development timelines.

The successful candidate will master submissions to SAHPRA, FDA, and EMA, oversee post-market activities, mentor staff, and ensure compliance with ICH, GCP, GMP guidelines while driving efficient, ethical approvals.

Qualifications

• 7+ years progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions in major markets.
• Excellent remote collaboration and communication skills.

Responsibilities

• Develop and implement global regulatory strategies for new drug applications and submissions.
• Prepare, review, and submit regulatory documents to SAHPRA, FDA, and EMA.
• Liaise directly with regulatory agencies to address queries and facilitate the approval process.
• Maintain up-to-date knowledge of evolving regulatory requirements and advise the organization accordingly.
• Oversee post-market regulatory activities, including variations, renewals, and compliance reporting.
• Mentor junior regulatory affairs personnel and contribute to the development of departmental processes and best practices.

Skills

Strategic thinking

Regulatory strategy

Project management

Remote collaboration

Communication skills

ICH/GCP/GMP knowledge

Education

Master's degree or PhD in Pharmacy, Chemistry, Life Sciences, or related field

Job description

About the Role

Our client is seeking a highly experienced and strategic Senior Regulatory Affairs Specialist to lead their regulatory efforts. This is a fully remote position, offering a unique opportunity to shape regulatory strategies from anywhere. You will be responsible for ensuring compliance with all relevant national and international regulations governing pharmaceutical products. This role requires a deep understanding of the drug development lifecycle, regulatory submission processes, and a proactive approach to navigating the complex regulatory landscape. Your expertise will be instrumental in bringing life-saving therapies to market efficiently and ethically.

Key Responsibilities

• Develop and implement global regulatory strategies for new drug applications (NDAs) and other regulatory submissions.


• Prepare, review, and submit regulatory documents to health authorities such as the SAHPRA, FDA, and EMA.


• Liaise directly with regulatory agencies to address queries and facilitate the approval process.


• Maintain up-to-date knowledge of evolving regulatory requirements and advise the organization accordingly.


• Oversee post-market regulatory activities, including variations, renewals, and compliance reporting.


• Mentor junior regulatory affairs personnel and contribute to the development of departmental processes and best practices.

Requirements

• Master's degree or PhD in Pharmacy, Chemistry, Life Sciences, or a related field.


• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.


• Proven track record of successful regulatory submissions and approvals in major markets.


• Extensive knowledge of ICH guidelines, GCP, GMP, and relevant regional regulations.


• Excellent strategic thinking, problem-solving, and project management skills.


• Exceptional written and verbal communication skills, essential for remote collaboration and agency interactions.

Benefits

• Highly competitive annual salary and bonus structure.


• Fully remote work arrangement with significant autonomy.


• Comprehensive executive-level health and wellness benefits.


• Generous vacation policy and opportunities for international travel.


• Professional development budget for conferences, training, and certifications.


• A dynamic and forward-thinking work culture with a focus on innovation.