Senior Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; Gqeberha; Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Pension

Bonuses

Career advancement

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for a dynamic pharmaceutical company. This role offers remote work from Port Elizabeth, Eastern Cape, while contributing to global regulatory strategy and submitting dossiers to health authorities worldwide.

You will prepare CTD/eCTD submissions, liaise with SAHPRA, FDA, and EMA, ensure compliance, guide R&D and clinical teams, and stay abreast of evolving guidelines.

Qualifications

• 5+ years of progressive pharmaceutical regulatory experience.
• Experience preparing and submitting regulatory dossiers to major health authorities.
• Strong knowledge of ICH, FDA, EMA, SAHPRA guidelines.
• Excellent written and verbal communication with technical writing skills.
• Ability to manage multiple projects in a remote, fast-paced environment.

Responsibilities

• Prepare regulatory dossiers (CTD/eCTD) for NDAs, MAAs, and variations.
• Liaise with health authorities (SAHPRA, FDA, EMA) to facilitate reviews.
• Ensure submissions comply with current guidelines and standards.
• Develop regulatory strategies for registration and lifecycle management.
• Review labeling and promotional materials for compliance.
• Provide regulatory guidance to R&D, clinical, and commercial teams.
• Stay updated on evolving regulatory requirements and best practices.
• Maintain regulatory databases and track submission status.

Skills

Regulatory affairs

Regulatory submissions

Project management

Regulatory strategy

Education

Bachelor's degree in Pharmacy

Master's degree in related field

Job description

About the Role

Our client, a dynamic and growing pharmaceutical company, is seeking an experienced Senior Regulatory Affairs Specialist to manage and execute regulatory submissions from their home office. This position offers the flexibility of a remote work arrangement, allowing you to contribute to our global regulatory strategy while enjoying the convenience of working from Port Elizabeth, Eastern Cape . You will be responsible for preparing, compiling, and submitting high-quality regulatory dossiers to health authorities worldwide, ensuring compliance with all relevant regulations and guidelines. This role is crucial for bringing innovative pharmaceutical products to market efficiently and effectively. The ideal candidate will have a strong understanding of global regulatory landscapes and a proven ability to navigate complex submission processes.

Key Responsibilities

• Prepare and assemble comprehensive regulatory submission dossiers (e.g., CTD, eCTD) for new drug applications (NDAs), marketing authorization applications (MAAs), and variations.
• Liaise with global health authorities (e.g., SAHPRA, FDA, EMA) to facilitate the review process and respond to queries.
• Ensure all regulatory submissions comply with current guidelines and company standards.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Review and approve labeling, promotional materials, and other product-related documents for regulatory compliance.
• Provide regulatory guidance and support to internal project teams, including R&D, clinical, and commercial departments.
• Stay updated on evolving regulatory requirements and industry best practices.
• Maintain regulatory databases and track submission status and approvals.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting various types of regulatory dossiers to major health authorities.
• In-depth knowledge of pharmaceutical regulatory guidelines (e.g., ICH, FDA, EMA, SAHPRA).
• Excellent understanding of the drug development process and product lifecycle management.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Exceptional written and verbal communication skills, with proficiency in technical writing.
• Proven ability to manage multiple projects simultaneously and work effectively in a remote, fast-paced environment.

Benefits

• Our client offers a highly competitive salary, a comprehensive benefits package including medical aid and pension, potential for performance-based bonuses, and substantial opportunities for career advancement.
• You will have the autonomy to shape your work environment while contributing to significant pharmaceutical milestones.