Remote Senior Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Sandton; Hybrid; ZAR 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Fully remote

Global exposure

Flexible location

Job summary

Placements24 is seeking an experienced Senior Regulatory Affairs Specialist for a fully remote role with flexibility to operate from Sandton, Gauteng, or other approved locations. You will drive regulatory submissions, provide strategic regulatory guidance, and liaise with health authorities across international markets.

The ideal candidate will have 6–8 years in pharmaceutical regulatory affairs, deep knowledge of FDA/EMA/SAHPRA/PMDA processes, and a track record in dossier preparation and

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or life sciences field.
• Advanced degree (MSc, PhD) or equivalent experience preferred.
• Minimum 6–8 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission processes (FDA, EMA, SAHPRA, PMDA).
• Proven experience in preparing and submitting regulatory dossiers.
• Strong understanding of product development, manufacturing, and QA.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD, IND, NDA) to health authorities globally.
• Interpret and advise on complex regulatory requirements and guidelines.
• Liaise with regulatory agencies on submissions, inquiries, and inspections.
• Develop regulatory strategies for new product development and lifecycle management.
• Ensure compliance with GMP, GCP, and GLP across activities.
• Manage post-approval regulatory activities (variations, renewals, annual reports).
• Collaborate with R&D, clinical operations, manufacturing, and legal teams on regulatory matters.
• Provide training on regulatory compliance to internal teams.
• Monitor regulatory intelligence and competitor activities.

Skills

Regulatory submissions

Regulatory strategy

GMP/GCP/GLP

Regulatory intelligence

Remote collaboration

Education

Bachelor's degree in Pharmacy / life sciences

Advanced degree (MSc/PhD) preferred

Tools

RIM systems

Job description

About the Role

Our client, a global leader in the pharmaceutical industry, is seeking an experienced Senior Regulatory Affairs Specialist to join their team in a fully remote capacity. This role is critical in ensuring that our pharmaceutical products meet all regulatory requirements for marketing and sale across various international markets. You will be responsible for preparing, reviewing, and submitting regulatory documentation, engaging with health authorities, and providing strategic regulatory guidance to project teams. The ideal candidate has a strong understanding of global pharmaceutical regulations and a proven track record in regulatory submissions. As a remote employee, you will have the flexibility to work from Sandton, Gauteng, or any approved location, contributing to our mission of bringing life-saving medicines to patients worldwide.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities globally.
• Interpret and advise on complex regulatory requirements and guidelines.
• Liaise with regulatory agencies on submissions, inquiries, and inspections.
• Develop regulatory strategies for new product development and lifecycle management.
• Ensure compliance with all applicable pharmaceutical regulations, including GMP, GCP, and GLP.
• Manage post-approval regulatory activities, such as variations, renewals, and annual reports.
• Collaborate with cross-functional teams, including R&D, clinical operations, manufacturing, and legal, to ensure alignment on regulatory matters.
• Provide training and guidance to internal teams on regulatory compliance.
• Monitor regulatory intelligence and competitor activities.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Advanced degree (MSc, PhD) or equivalent experience preferred.
• Minimum of 6-8 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission processes and requirements (e.g., FDA, EMA, SAHPRA, PMDA).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Strong understanding of pharmaceutical product development, manufacturing, and quality assurance.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information.
• Demonstrated ability to manage multiple projects and prioritize effectively in a remote environment.
• Experience working with regulatory information management (RIM) systems is a plus.
• High degree of integrity and ethical conduct.

Benefits

• Our client offers a highly competitive salary, a comprehensive benefits package, and the unique advantage of a fully remote work arrangement.
• This position provides the opportunity to make a significant impact on global regulatory strategies while working from Sandton, Gauteng, or any suitable location, offering excellent flexibility.
• Continuous professional development, including access to regulatory training and conferences, is a key benefit.
• Our client is committed to fostering a collaborative and innovative remote work culture.
• Performance bonuses and retirement savings plans are also provided.