Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Remote work flexibility

Professional development

Paid time off

Job summary

Placements24 in South Africa seeks a highly experienced Remote Pharmaceutical Regulatory Affairs Specialist to navigate global regulatory landscapes, manage submissions, and ensure compliance for a diverse portfolio across international markets. You will lead regulatory strategy, liaise with authorities, and collaborate with R&D, manufacturing, and marketing in a fully remote setup.

The role requires 7+ years in regulatory affairs, strong knowledge of FDA/EMA/PMDA guidelines, and a proven track

Qualifications

• Bachelor's or Master's in life science, pharmacy, or related field; PhD a plus.
• Minimum 7 years in pharmaceutical regulatory affairs with global scope.
• Proven track record of successful regulatory submissions and approvals.
• Strong knowledge of drug development, GMP/GCP, and manufacturing basics.
• Experience with eCTD and multiple submission formats.
• Analytical, strategic thinker with excellent written and verbal communication.
• Ability to work independently and manage multiple remote projects.

Responsibilities

• Prepare, review, and submit regulatory documentation for filings worldwide.
• Develop global regulatory strategies to support development and commercialization.
• Monitor evolving guidelines; advise on impact to products and operations.
• Liaise with health authorities during submissions and reviews.
• Ensure compliance with local and international regulations and guidelines.
• Conduct regulatory intelligence to identify trends and risks.
• Collaborate with R&D, clinical operations, manufacturing, and marketing.
• Manage post-approval lifecycle activities and compliance reporting.

Skills

Regulatory affairs

Regulatory strategy

Analytical thinking

Communication

Project management

Remote work

Decision making

Education

Bachelor's or Master's in life science/pharmacy

PhD or advanced degree a plus

Tools

eCTD

Regulatory databases

Job description

About the Role

Our client, a distinguished leader in the pharmaceutical industry, is actively seeking a highly experienced Remote Pharmaceutical Regulatory Affairs Specialist to join their globally distributed team. This role is critical for navigating the complex regulatory landscape and ensuring compliance for our diverse portfolio of pharmaceutical products across various international markets. The successful candidate will leverage their expertise in regulatory submissions, strategy, and compliance to support product lifecycle management and market authorization. This is a fully remote position, offering the flexibility and autonomy to work from anywhere within the required operational time zones, fostering unparalleled work-life integration. You will be an integral part of a forward-thinking organization dedicated to innovation and global health.

Key Responsibilities

• Prepare, review, and submit regulatory documentation (e.g., CTDs, dossiers) for new drug applications (NDAs), variations, and renewals to health authorities worldwide.
• Develop and implement global regulatory strategies to support product development and commercialization.
• Monitor and interpret evolving regulatory guidelines and policies in key markets, advising on their impact on the company's products and operations.
• Liaise with health authorities during the submission and review processes, responding to queries and addressing deficiencies.
• Ensure compliance with all applicable local and international pharmaceutical regulations and guidelines.
• Conduct regulatory intelligence activities, identifying emerging trends and potential risks.
• Collaborate closely with cross-functional teams, including R&D, clinical operations, manufacturing, and marketing, to align regulatory strategies with business objectives.
• Manage post-approval regulatory activities, including lifecycle management and compliance reporting.

Requirements

• Bachelor's or Master's degree in a life science, pharmacy, or related field. A Ph.D. or advanced degree is a plus.
• A minimum of 7 years of comprehensive experience in pharmaceutical regulatory affairs, with a strong understanding of global regulatory requirements (e.g., FDA, EMA, PMDA).
• Proven track record of successful regulatory submissions and approvals.
• Extensive knowledge of drug development processes and pharmaceutical manufacturing.
• Experience with various regulatory submission formats, including eCTD.
• Exceptional analytical, problem-solving, and strategic thinking capabilities.
• Excellent written and verbal communication skills, with the ability to influence and negotiate effectively.
• Demonstrated ability to work independently and manage multiple projects simultaneously in a remote setting.
• Strong understanding of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).

Benefits

• Our client offers a highly competitive salary commensurate with experience, along with potential bonuses.
• Comprehensive benefits include premium health, dental, and vision insurance.
• We provide a robust retirement savings plan with company matching.
• This fully remote position offers significant flexibility, allowing you to manage your work schedule effectively.
• Opportunities for continuous professional development, attending international conferences, and career progression are abundant.
• Paid time off and holidays are provided in accordance with company policy.