Pharmaceutical Regulatory Affairs Specialist

Placements24; Polokwane; On-site; ZAR 540,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, and vision insurance

Generous paid time off

Retirement savings plan with company-m

Professional development and training

Life insurance and disability benefits

Employee assistance program

Job summary

Placements24 in Polokwane seeks a Pharmaceutical Regulatory Affairs Specialist to manage regulatory submissions, filings, and compliance throughout product lifecycle. You will liaise with health authorities and guide internal teams on regulatory strategy.

The ideal candidate has a pharmacy/chemistry/biology degree with at least 3 years in regulatory affairs, strong documentation discipline, and excellent communication to support product approvals and market maintenance.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related scientific discipline.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory requirements for drug approval and post-approval in relevant markets.
• Experience with preparing and submitting dossiers (CTD format).
• Strong understanding of GMP and pharmacovigilance requirements.
• Excellent written and verbal communication skills.

Responsibilities

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals.
• Maintain regulatory filings and ensure compliance with applicable regulations.
• Liaise with regulatory agencies, health authorities, and other stakeholders.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Monitor regulatory changes and assess their impact on the company's products and operations.
• Review promotional materials for regulatory compliance.
• Participate in regulatory audits and inspections.
• Contribute to the development and implementation of regulatory strategies.
• Ensure that all regulatory activities are conducted in accordance with company policies and procedures.

Skills

Regulatory knowledge

Documentation quality

Communication skills

Organizational skills

Team collaboration

Problem-solving

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Tools

Regulatory information management systems

Job description

About the Role

Our client, a leading pharmaceutical company, is seeking a dedicated Pharmaceutical Regulatory Affairs Specialist to join their team in Polokwane . This role is crucial for ensuring that our products comply with all relevant national and international regulatory standards throughout their lifecycle. You will be responsible for preparing, submitting, and maintaining regulatory documentation, liaising with health authorities, and providing regulatory guidance to internal teams. The ideal candidate will possess a strong understanding of pharmaceutical regulations, a meticulous approach to documentation, and excellent communication skills. You will play a key role in facilitating the approval and marketing of our innovative pharmaceutical products, contributing directly to our mission of improving patient health. This is an excellent opportunity for a motivated regulatory professional to grow their career within a supportive and forward-thinking organization.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals.
• Maintain regulatory filings and ensure compliance with applicable regulations.
• Liaise with regulatory agencies, health authorities, and other stakeholders.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Monitor regulatory changes and assess their impact on the company's products and operations.
• Review promotional materials for regulatory compliance.
• Participate in regulatory audits and inspections.
• Contribute to the development and implementation of regulatory strategies.
• Ensure that all regulatory activities are conducted in accordance with company policies and procedures.
• Stay current with the latest regulatory guidelines and best practices.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory requirements for drug approval and post-approval in relevant markets.
• Experience with preparing and submitting dossiers (e.g., CTD format).
• Strong understanding of GMP and pharmacovigilance requirements.
• Excellent written and verbal communication skills.
• Meticulous attention to detail and strong organizational skills.
• Ability to work independently and as part of a team.
• Proficiency in regulatory information management systems is a plus.
• Problem-solving skills and a proactive approach.

Benefits

• Competitive salary and annual bonus.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• Retirement savings plan with company matching.
• Opportunities for professional development and training in regulatory affairs.
• Work within a reputable pharmaceutical company in Polokwane .
• Collaborative team environment.
• Career growth prospects.
• Life insurance and disability benefits.
• Employee assistance program.