Senior Regulatory Affairs Specialist

Placements24; Richards Bay; In loco; ZAR 900.000 - 1.300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Performance incentives

Health and wellness benefits

Retirement savings plan

Travel opportunities (international &/

Professional development and training

Exposure to diverse regulatory regimes

Supportive and dynamic workenv

Descrizione del lavoro

Placements24 is seeking a Senior Regulatory Affairs Specialist for our client’s Richards Bay, KwaZulu-Natal operations. You will lead regulatory strategies, prepare and submit CTD/eCTD dossiers, liaise with authorities, and ensure ongoing compliance across global markets.

The ideal candidate has 6+ years in regulatory affairs, deep regulatory knowledge, and strong communication skills. This role requires collaboration with R&D, QA, and commercial teams to align regulatory plans with business

Competenze

• Bachelor’s degree in Pharmacy or Life Sciences.
• Minimum of 6 years in pharmaceutical regulatory affairs.
• Deep knowledge of FDA, EMA, and SAHPRA requirements.
• Experience preparing/regulatory dossiers for multiple regions.
• Excellent written and spoken communication skills.
• Ability to work under pressure and meet deadlines.
• Experience in Richards Bay or similar industrial environments is a plus.

Mansioni

• Develop regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit CTD/eCTD dossiers to health authorities globally.
• Liaise with regulatory agencies to address queries and facilitate approvals.
• Monitor evolving regulatory guidelines and advise on compliance strategies.
• Manage post-approval changes and maintain ongoing compliance.
• Provide regulatory input to development teams and product opportunities assessment.
• Maintain regulatory databases and documentation systems.
• Collaborate with cross-functional teams to ensure compliance across operations.

Conoscenze

Regulatory affairs

Pharma regulations

Dossier submission

CTD/eCTD submissions

Formazione

Bachelor’s degree in Pharmacy or Life Sciences

Advanced degree preferred

Strumenti

Regulatory information systems

Descrizione del lavoro

About the Role

Our client, a significant player in the pharmaceutical industry, is seeking a seasoned Senior Regulatory Affairs Specialist for their operations in Richards Bay, KwaZulu-Natal. This role is critical for ensuring that all products meet the necessary regulatory requirements for market approval and continued compliance. You will be responsible for preparing, submitting, and managing regulatory dossiers for new drug applications and variations across various global markets. The ideal candidate possesses a deep understanding of international pharmaceutical regulations, excellent communication skills, and a meticulous approach to documentation. You will work closely with R&D, quality assurance, and commercial teams to align regulatory strategies with business objectives, ensuring timely access to medicines for patients in Richards Bay and beyond. This is a key position within a growth-oriented pharmaceutical company.

Key Responsibilities

• Develop and implement regulatory strategies for product registration and lifecycle management.


• Prepare, review, and submit regulatory dossiers (e.g., CTD, eCTD) to health authorities globally.


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


• Monitor and interpret evolving regulatory guidelines and advise the organization on compliance strategies.


• Manage post-approval changes and ensure ongoing compliance with regulatory requirements.


• Provide regulatory input and support to product development teams.


• Conduct regulatory assessments for new product opportunities and market entries.


• Maintain regulatory databases and documentation systems.


• Collaborate with cross-functional teams to ensure regulatory compliance across all operations.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related discipline; advanced degree preferred.


• Minimum of 6 years of experience in pharmaceutical regulatory affairs.


• In-depth knowledge of pharmaceutical regulations (e.g., FDA, EMA, SAHPRA) and guidelines.


• Proven experience in preparing and submitting regulatory dossiers for various regions.


• Excellent written and verbal communication skills, with strong attention to detail.


• Ability to work effectively under pressure and meet tight deadlines.


• Strong analytical and problem-solving skills.


• Experience in Richards Bay, KwaZulu-Natal or similar industrial environment is beneficial.


• Proficiency in regulatory information management systems.

Benefits

• An attractive annual salary with performance incentives.


• Comprehensive health and wellness benefits.


• Retirement savings plan.


• Opportunities for international and domestic travel.


• Continuous professional development and training programs.


• Exposure to diverse regulatory landscapes.


• A supportive and dynamic work environment.