Senior Regulatory Affairs Specialist

Placements24; Willows (CA); Remote; USD 54,000 - 78,000; Full time

Benefits offered by this job

Home office stipend

IT support for remote work

Health insurance

Job summary

Placements24 seeks a Senior Regulatory Affairs Specialist to join a dynamic pharmaceutical manufacturer in a remote capacity. The role focuses on ensuring compliance with SAHPRA and international guidelines, preparing regulatory dossiers, and guiding cross-functional teams on regulatory strategies.

The ideal candidate has 6+ years in regulatory affairs, strong analytical skills, and the ability to work independently under tight deadlines from a remote setting. Master’s degree is a plus.

Qualifications

• 6+ years of progressive experience in pharmaceutical regulatory affairs.
• Thorough knowledge of SAHPRA and ICH guidelines.
• Experience preparing and submitting registration dossiers for various product types.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD format) for new product registrations and variations.
• Liaise with regulatory agencies, respond to queries and address deficiencies promptly.
• Monitor regulatory changes and assess impact on products and operations.
• Develop regulatory strategies to support product development and lifecycle management.
• Review labeling, packaging, and promotional materials for compliance.
• Provide regulatory guidance to R&D, marketing, and manufacturing teams.
• Maintain regulatory databases and ensure accurate record-keeping.
• Manage post-approval activities including renewals and change controls.

Skills

Regulatory affairs

Dossier submission

SAHPRA knowledge

Remote work capable

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Master's degree or equivalent

Tools

RIM systems

MS Office

Job description

About the Role

Our client, a dynamic pharmaceutical manufacturer, is seeking an experienced Senior Regulatory Affairs Specialist to enhance their team in Welkom, Free State . This role is critical for ensuring that all products comply with national and international regulatory standards. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing strategic regulatory guidance to cross-functional teams. The ideal candidate will possess a strong understanding of pharmaceutical regulations and a proactive approach to regulatory challenges. This is an exceptional opportunity to contribute to the success of a growing company and to play a key role in bringing safe and effective medicines to market from a remote capacity.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) for new product registrations and variations in accordance with SAHPRA and other relevant authorities.
• Liaise directly with regulatory agencies, responding to queries and addressing deficiencies in a timely manner.
• Monitor and interpret changes in regulatory legislation and guidance, assessing their impact on the company's products and operations.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Review promotional materials, labeling, and packaging to ensure regulatory compliance.
• Provide regulatory guidance and support to R&D, marketing, and manufacturing departments.
• Maintain regulatory databases and ensure accurate record-keeping.
• Manage post-approval regulatory activities, including annual renewals and change controls.
• Ensure all regulatory submissions and activities related to products available in Welkom and beyond meet the highest standards.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
• Master's degree or equivalent experience is a plus.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• Thorough knowledge of South African pharmaceutical regulations (SAHPRA) and international guidelines (e.g., ICH).
• Proven experience in preparing and submitting registration dossiers for various product types.
• Strong analytical skills and the ability to interpret complex regulatory information.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage multiple projects, and meet tight deadlines in a remote setting.
• Proficiency in regulatory information management (RIM) systems and MS Office Suite.
• Demonstrated ability to navigate the regulatory landscape effectively for products intended for markets including Welkom .

Benefits

• Competitive annual salary package of ZAR .
• Performance-based incentives.
• Home office stipend and IT support for remote work.
• Comprehensive health insurance and retirement savings plan.
• Opportunities for continued professional development and training.
• Flexible working hours and the ability to work from home, supporting the Welkom region.