Senior Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; Benoni; Hybride; ZAR 900 000 - 1 500 000; Plein temps

Avantages offerts par ce poste

Health insurance

Pension plan

Paid time off

Professional growth

Résumé du poste

Placements24 in Benoni, Gauteng seeks a Senior Regulatory Affairs Specialist to guide regulatory strategy and ensure compliance across SA, Europe, and the US. You will prepare, submit, and manage regulatory dossiers, interact with health authorities, and lead cross-functional teams through product lifecycle.

The ideal candidate holds a life sciences degree, 5+ years in regulatory affairs, CTD experience, and strong communication. Fluency in English is essential.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related life science.
• Master's degree or equivalent experience preferred.
• Minimum of 5 years in pharmaceutical regulatory affairs; CTD experience.

Responsabilités

• Prepare, review, and submit regulatory dossiers for NDAs, variations, and renewals.
• Develop regulatory strategies for product development and lifecycle management.
• Liaise with SAHPRA, FDA, EMA and other authorities; respond to queries.
• Ensure compliance with regulations, guidelines, and company policies.
• Provide regulatory guidance to R&D, manufacturing, and marketing teams.
• Monitor regulatory environment changes and their impact on products.
• Maintain regulatory documents and participate in inspections and audits.
• Manage post-approval commitments and variations.
• Contribute to regulatory SOPs and best practices.

Connaissances

Analytical skills

Problem-solving

Critical thinking

Written communication

Verbal communication

Regulatory information management

Independent work

Multitasking

Formation

Bachelor's degree in Pharmacy/ Chemistry/ Biology or related life science

Master's degree or equivalent experience

Outils

CTD knowledge

Regulatory databases

Description du poste

About the Role

Our client, a progressive pharmaceutical company dedicated to bringing innovative therapies to market, is seeking a highly skilled Senior Regulatory Affairs Specialist to join their esteemed team in Benoni, Gauteng . This integral role focuses on ensuring that our client's pharmaceutical products comply with all relevant national and international regulations throughout their lifecycle. You will be responsible for preparing, submitting, and managing regulatory dossiers, liaising with health authorities, and providing expert guidance on regulatory strategy. The ideal candidate possesses a meticulous approach, a comprehensive understanding of pharmaceutical regulatory landscapes, and exceptional communication skills. This position offers a substantial opportunity to influence regulatory pathways and contribute to patient access to critical medicines within the pharmaceutical industry, based in the dynamic environment of Benoni.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals to health authorities (e.g., SAHPRA, FDA, EMA).
• Develop and implement regulatory strategies for product development and lifecycle management.
• Liaise with national and international regulatory agencies, responding to queries and facilitating approvals.
• Ensure compliance with all applicable regulations, guidelines, and company policies.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Monitor changes in the regulatory environment and assess their impact on company products and strategies.
• Maintain regulatory databases and ensure the accuracy of regulatory documentation.
• Participate in regulatory inspections and audits.
• Manage post-approval commitments and variations.
• Contribute to the development and implementation of regulatory affairs SOPs and best practices.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• A Master's degree or equivalent experience is preferred.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory submission requirements and guidelines in key markets (e.g., South Africa, Europe, USA).
• Proven experience in preparing and submitting various types of regulatory dossiers (e.g., CTD).
• Familiarity with drug development processes and manufacturing principles.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
• Proficiency in regulatory information management systems and databases.
• Ability to work independently and manage multiple projects simultaneously.
• Meticulous attention to detail and a commitment to accuracy.
• Experience with biosimilars or generic drug applications is a plus.
• Fluency in English is essential; proficiency in other languages is an advantage.

Benefits

• Our client offers a highly competitive salary package, supplemented by performance-based incentives and bonuses.
• Comprehensive health insurance, covering medical, dental, and vision care, is provided to employees and their dependents.
• A generous paid time off policy, including vacation days, sick leave, and public holidays, is in place.
• Opportunities for professional growth, such as attendance at international regulatory affairs conferences and specialized training programs, are actively supported.
• A retirement savings plan with employer contributions enhances long-term financial security.
• The role provides a challenging and rewarding work environment in Benoni, where you can make a significant impact on regulatory strategy and global health outcomes.
• Our client is dedicated to nurturing talent and offers substantial career advancement opportunities within the pharmaceutical industry.