Senior Pharmaceutical Regulatory Affairs Specialist

Placements24; Paarl; Ibrido; ZAR 1.994.000 - 2.991.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

Retirement plan

Generous PTO

Remote-friendly

Descrizione del lavoro

Placements24 seeks a Senior Pharmaceutical Regulatory Affairs Specialist for a fully remote role, supporting global market approvals and ongoing compliance. You will prepare regulatory dossiers, liaise with authorities, and guide strategy across SAHPRA, FDA, and EMA.

Ideal candidates have 5+ years in regulatory affairs, strong ICH/cGMP knowledge, and excellent communication. Remote-first environment with global collaboration and growth opportunities.

Competenze

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field.
• 5+ years in pharmaceutical regulatory affairs.
• Proven experience preparing/submitting dossiers to SAHPRA, FDA, EMA.
• Deep knowledge of ICH guidelines, cGMP, and related frameworks.
• Strong written and verbal communication, with deadline-driven focus.

Mansioni

• Prepare, review, and submit regulatory submissions (CTD, ANDA, NDA) to health authorities.
• Manage lifecycle of regulatory filings, including variations, renewals, and annual reports.
• Interpret and advise on global regulatory requirements for product development and registration.
• Serve as primary contact with regulatory agencies for assigned projects.
• Develop and implement regulatory strategies to support development and commercialization.
• Collaborate with R&D, Clinical, Manufacturing, Marketing to align on regulatory matters.
• Lead or participate in regulatory inspections and respond to inquiries.

Conoscenze

Regulatory expertise

Attention to detail

Communication

Formazione

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Advanced degree (Master's/Ph.D.) is a plus

Strumenti

Regulatory submission tools

RIMS

Descrizione del lavoro

About the Role

Our client, a renowned pharmaceutical company known for its commitment to innovation and quality, is actively seeking a Senior Pharmaceutical Regulatory Affairs Specialist for a fully remote position. This role is critical in ensuring that our client's pharmaceutical products meet all relevant regulatory requirements for market approval and compliance across various international markets. You will be responsible for preparing, submitting, and maintaining regulatory dossiers, liaising with health authorities, and providing expert guidance on regulatory strategies. This is a remote-first opportunity, requiring excellent self-management, communication, and collaboration skills to work effectively with global teams. Your expertise will be instrumental in navigating the complex regulatory landscape and bringing life-saving medications to patients worldwide. We are looking for a proactive and detail-oriented professional who thrives in a virtual, fast-paced environment.

Key Responsibilities

• Prepare, review, and submit high-quality regulatory submissions (e.g., CTD, ANDA, NDA) to health authorities.
• Manage the lifecycle of regulatory filings, including variations, renewals, and annual reports.
• Interpret and advise on global regulatory requirements and guidelines relevant to pharmaceutical product development and registration.
• Serve as the primary point of contact with regulatory agencies for assigned projects.
• Develop and implement regulatory strategies to support product development and commercialization.
• Conduct regulatory due diligence for potential partnerships or acquisitions.
• Review promotional materials and labeling to ensure compliance with regulations.
• Collaborate effectively with internal teams (R&D, Clinical, Manufacturing, Marketing) to ensure alignment on regulatory matters.
• Stay updated on evolving regulatory landscapes and provide proactive guidance.
• Lead or participate in regulatory authority inspections and respond to queries.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; Advanced degree (Master's/Ph.D.) is a plus.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting various types of regulatory dossiers to major health authorities (e.g., SAHPRA, FDA, EMA).
• In-depth knowledge of ICH guidelines, cGMP, and other relevant regulatory frameworks.
• Strong understanding of drug development processes and product lifecycles.
• Excellent written and verbal communication skills, with meticulous attention to detail.
• Demonstrated ability to work independently, manage multiple priorities, and meet tight deadlines in a remote setting.
• Strong analytical and problem-solving capabilities.
• Experience with electronic submission tools and regulatory information management systems is desirable.

Benefits

• Our client offers a competitive salary, comprehensive health and wellness benefits, a retirement savings plan, and generous paid time off.
• This fully remote role provides significant flexibility and the opportunity to work from anywhere.
• You will have access to continuous professional development resources and be part of a global team dedicated to making a difference in healthcare.
• We provide the necessary tools and support for our remote workforce to thrive, fostering a culture of innovation and collaboration.