Regulatory Affairs Specialist

Placements24; Willows (CA); Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Remote salary package

Performance bonuses

Medical & life insurance

Professional development opportunities

Flexible working hours

Job summary

Placements24 is seeking an experienced Regulatory Affairs Specialist to manage regulatory compliance for pharmaceutical products in the Free State region. You will prepare and submit dossiers, liaise with authorities, and ensure ongoing compliance across development, manufacturing, and marketing.

The role emphasizes remote work with focus on timely approvals, market access, and staying abreast of regulatory changes global and local. Collaboration with R&D and manufacturing is essential.

Qualifications

• Bachelor's degree in a scientific field required.
• Minimum 4 years of Regulatory Affairs experience in pharma.
• Familiarity with SAHPRA or equivalent regulatory systems.
• CTD dossier preparation experience preferred.

Responsibilities

• Prepare and submit regulatory dossiers for registrations, variations, and renewals.
• Liaise with regulators to secure approvals and address queries.
• Monitor regulatory changes and assess impact on products and processes.
• Ensure compliance with pharmaceutical regulations, guidelines, and internal policies.
• Provide regulatory support to R&D, manufacturing, and marketing teams.

Skills

Analytical skills

Regulatory affairs

Project management

Written & verbal communication

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Chemistry

Bachelor's degree in Life Sciences

Master's degree (advantage)

Job description

About the Role

Our client is seeking an experienced and knowledgeable Regulatory Affairs Specialist to manage regulatory compliance for their pharmaceutical products within the Free State region. This role is pivotal in ensuring that all product development, manufacturing, and marketing activities align with national and international regulatory standards, including those set by the South African Health Products Regulatory Authority (SAHPRA). You will play a key role in preparing and submitting regulatory dossiers, facilitating approvals, and maintaining compliance throughout the product lifecycle. This is an excellent remote opportunity to significantly impact market access for vital pharmaceutical innovations.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for new product registrations, variations, and renewals.
• Liaise with regulatory authorities to ensure timely approval of submissions and respond to queries.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.
• Ensure compliance with all relevant pharmaceutical regulations, guidelines, and company policies.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Maintain regulatory databases and documentation systems, ensuring accuracy and completeness.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; a Master's degree is advantageous.
• Minimum of 4 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Thorough understanding of South African pharmaceutical regulations and submission processes.
• Experience with dossier preparation using Common Technical Document (CTD) format.
• Strong analytical, problem-solving, and project management skills.
• Excellent written and verbal communication skills, with the ability to negotiate effectively with regulatory bodies.

Benefits

• Competitive remote salary package.
• Performance-based bonuses.
• Comprehensive medical aid and life insurance.
• Opportunities for professional development and attending industry conferences.
• Flexible working hours to support work-life balance.