Senior Regulatory Affairs Specialist

Placements24; Paarl; Remote; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Performance bonuses

Medical aid

Retirement provisions

Flexible remote work

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist to join our team. This primarily remote role focuses on regulatory compliance for pharmaceutical products across international markets, with emphasis on Paarl, Western Cape.

You will prepare, submit, and maintain filings, liaise with health authorities, and guide internal teams on regulatory strategy. The ideal candidate has at least 6 years in pharmaceutical regulatory affairs, strong knowledge of FDA/EMA/SAHPRA guidelines, and

Qualifications

• 6+ years of progressive experience in pharmaceutical regulatory affairs.
• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field; Master's preferred.
• Deep knowledge of global regulatory submission requirements (FDA, EMA, SAHPRA).
• Experience preparing and managing regulatory submissions for various product types.
• Strong communication and project management skills; ability to meet tight deadlines.
• Eligible to work remotely in South Africa.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities worldwide.
• Manage post-approval regulatory activities: amendments, renewals, variations.
• Interpret and apply global regulatory guidelines.
• Liaise with regulatory agencies; respond to queries and inspections.
• Provide regulatory guidance to cross-functional teams.
• Develop and maintain regulatory strategies for development and lifecycle management.
• Review promotional and labeling materials for regulatory compliance.
• Maintain regulatory documentation and databases.
• Stay abreast of changes in the regulatory environment and assess impact.

Skills

Regulatory submissions

Global regulatory guidelines

Cross-functional collaboration

Communication skills

Analytical thinking

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Master's degree preferred

Tools

Regulatory information management systems

Job description

About the Role Our client, a forward-thinking pharmaceutical company with a growing global presence, is seeking an experienced Senior Regulatory Affairs Specialist to join their team. This position will be primarily remote, with the flexibility to work from home, and will focus on ensuring compliance with regulatory requirements for pharmaceutical products in various international markets, with a focus on operations relevant to **Paarl, Western Cape**. You will be responsible for preparing, submitting, and maintaining regulatory filings, liaising with health authorities, and providing regulatory guidance to internal teams. The ideal candidate will possess a deep understanding of global regulatory landscapes, strong analytical skills, and excellent communication abilities. This is an excellent opportunity for a seasoned regulatory professional to contribute significantly to the market access of innovative medicines from a strategic location like **Paarl, Western Cape**, while enjoying the benefits of a remote work arrangement.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., CTD, ANDA, MAA) to health authorities worldwide.
• Manage post-approval regulatory activities, including amendments, renewals, and variations.
• Interpret and apply global regulatory guidelines and requirements to company products and processes.
• Liaise effectively with regulatory agencies, including responding to queries and facilitating inspections.
• Provide regulatory guidance and strategic advice to cross-functional teams (e.g., R&D, Marketing, Manufacturing).
• Develop and maintain regulatory strategies for product development and lifecycle management.
• Review promotional and labeling materials for regulatory compliance.
• Stay abreast of changes in the regulatory environment and assess their impact on the company.
• Maintain regulatory documentation and databases.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field. A Master's degree or equivalent is preferred.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission requirements and guidelines (e.g., FDA, EMA, SAHPRA).
• Proven experience in preparing and managing regulatory submissions for various product types.
• Excellent analytical, critical thinking, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to present complex information clearly.
• Demonstrated ability to manage multiple projects and meet tight deadlines.
• Proficiency in regulatory information management systems is a plus.
• Must be legally authorized to work in **South Africa** and capable of working remotely effectively.

Benefits

• This role offers a competitive salary, performance bonuses, and a comprehensive benefits package including medical aid and retirement provisions.
• The remote nature of the job provides excellent work-life balance and flexibility.
• Opportunities for professional development and attending industry conferences are provided.

Our client, operating with a strategic focus that includes **Paarl, Western Cape**, is committed to innovation and compliance, offering a challenging and rewarding career path.