Remote Senior Regulatory Affairs Specialist - Pharmaceutical Compliance

Placements24; Soweto; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Bonuses

Professional development

Remote work

Paid time off

Home office support

Regulatory intelligence

Job summary

Placements24 is seeking a highly experienced Remote Senior Regulatory Affairs Specialist to support global product registrations and life-cycle management from a home-based setting.

The role requires leadership in regulatory submissions, strategic guidance, and collaboration with cross-functional teams to ensure compliance and timely market access.

Qualifications

• Bachelor’s degree in a relevant life sciences field with strong regulatory background.
• Experience in international regulatory submissions and life-cycle management.
• Proven ability to develop regulatory strategies and manage complex projects.

Responsibilities

• Prepare, review, and submit regulatory documentation (CTD, NDAs, MAAs) to health authorities globally.
• Develop and implement regulatory strategies for new registrations and lifecycle management.
• Act as primary contact with regulatory agencies and address deficiencies.
• Interpret evolving global requirements and provide regulatory guidance.
• Collaborate with R&D, Clinical, Manufacturing, and Legal to align strategies.
• Manage post-approval activities including variations and annual reports.
• Review promotional materials and labeling for compliance.
• Maintain regulatory databases and documentation systems.

Skills

Regulatory affairs

Regulatory submissions

Regulatory strategy

Analytical skills

Written & verbal communication

Education

Bachelor's degree in Pharmacy, Life Sciences, Chemistry

Master's degree preferred

Tools

RIMS

DMS

Job description

About the Role

Our client, a prominent global pharmaceutical organization, is seeking a highly experienced and detail-oriented Remote Senior Regulatory Affairs Specialist to strengthen their compliance team. This critical role involves navigating the complex landscape of pharmaceutical regulations to ensure the successful registration and marketing of products worldwide. The specialist will be responsible for preparing, compiling, and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance throughout the product lifecycle. This is a fully remote opportunity, allowing you to contribute significantly to global health initiatives from your home office. The ideal candidate possesses a profound understanding of international regulatory requirements, excellent analytical skills, and a proven ability to manage multiple submissions concurrently. If you are a proactive regulatory professional passionate about ensuring patient access to safe and effective medicines and thrive in an independent, home-based work environment, this is an exceptional career advancement opportunity.

Key Responsibilities

• Prepare, review, and submit high-quality regulatory documentation (e.g., CTD, NDAs, MAAs) to health authorities globally.
• Develop and implement regulatory strategies for new product registrations and lifecycle management.
• Serve as the primary point of contact with regulatory agencies, responding to inquiries and addressing regulatory deficiencies.
• Interpret and provide guidance on evolving global regulatory requirements, guidelines, and standards.
• Conduct regulatory intelligence activities to stay informed about changes in the regulatory environment.
• Collaborate with cross-functional teams (e.g., R&D, Clinical, Manufacturing, Legal) to ensure alignment on regulatory strategies and submission requirements.
• Manage post-approval regulatory activities, including supplements, variations, and annual reports.
• Review promotional materials and labeling to ensure compliance with regulatory guidelines.
• Assess the regulatory impact of product changes and manufacturing modifications.
• Maintain regulatory databases and documentation systems.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
• A Master's or advanced degree is highly preferred.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs, with a strong focus on international submissions.
• In-depth knowledge of global regulatory submission requirements (e.g., ICH, FDA, EMA, PMDA).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Demonstrated ability to develop effective regulatory strategies and manage complex projects.
• Excellent analytical, critical thinking, and problem-solving skills.
• Outstanding written and verbal communication skills, with meticulous attention to detail.
• Proficiency in regulatory information management systems (RIMS) and document management systems (DMS).
• Ability to work independently, manage priorities effectively, and meet tight deadlines in a remote setting.
• Strong negotiation and influencing skills when interacting with health authorities.

Benefits

• Highly competitive annual salary of R .
• Comprehensive health, dental, and vision insurance coverage.
• Generous retirement savings plan with company match.
• Performance-based bonuses and annual incentives.
• Significant opportunities for professional development and specialized training.
• Flexible work schedule inherent to a remote role.
• Company-provided technology and home office support.
• Paid time off and company holidays.
• Access to global regulatory intelligence resources.
• Employee assistance program for personal and professional support.