Pharma Regulatory Affairs Specialist For Growth & Impact

Placements24; Polokwane; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary and annual bonus

Health, dental, and vision insurance

Generous paid time off and holidays

Retirement savings plan with company匹

Job summary

Placements24 seeks a Pharmaceutical Regulatory Affairs Specialist to join their Polokwane team, ensuring compliance with national and international regulatory standards throughout product lifecycles.

You will prepare, submit, and maintain regulatory documentation, liaise with health authorities, and guide cross-functional teams on GMP, pharmacovigilance, and CTD dossiers, with opportunities for professional growth in a forward-thinking organization.

Qualifications

• 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.

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.

Skills

Regulatory affairs

CTD dossiers

GMP knowledge

Pharmacovigilance

Documentation

Regulatory liaison

Communication

Detail oriented

Teamwork

Independent work

Education

Bachelor's degree in Pharmacy

Chemistry

Biology

Related scientific discipline

Tools

Regulatory information management systems

Job description

Pharmaceutical Regulatory Affairs Specialist

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.