Senior Pharmaceutical Regulatory Affairs Specialist (Remote)

Placements24; Gqeberha; Híbrido; ZAR 900.000 - 1.500.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical aid

Performance-based bonus

Remote work

Descripción de la vacante

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join a dynamic, remote-enabled team. You will lead global submissions (NDAs, MAAs, ANDAs), prepare and review CTD modules, and liaise with authorities (SAHPRA, FDA, EMA) to obtain approvals while ensuring compliance.

The role requires 5+ years in regulatory affairs, a degree in Pharmacy or Life Sciences, and strong knowledge of eCTD and RIM systems.

Formación

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or related field.
• Minimum 5 years in pharmaceutical regulatory affairs with global submissions.
• Proven experience preparing NDAs, MAAs, and ANDAs.
• Strong knowledge of SAHPRA, FDA, and EMA submission requirements.
• Experience with eCTD publishing and regulatory information management systems.

Responsabilidades

• Develop and implement regulatory strategies for NDAs/MAAs/other submissions.
• Prepare, review, and manage CTD modules and submission dossiers.
• Liaise with health authorities on requirements, deficiencies, and approvals.
• Monitor global guidelines and advise impact on products and strategies.
• Manage post-approval activities including variations and lifecycle management.
• Collaborate with R&D, QA, and Commercial to gather data for submissions.
• Maintain regulatory databases and tracking systems.
• Provide regulatory guidance to internal stakeholders and participate in inspections.

Conocimientos

Regulatory strategy

Global submissions

eCTD publishing

Cross-functional collaboration

Independent work

Educación

Bachelor's or Master's degree in Pharmacy/Life Sciences/Chemistry

Herramientas

eCTD publishing software

RIM systems

Descripción del empleo

Our client, a dynamic and rapidly growing pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their team. This is a fully remote position, allowing you to contribute to global health initiatives from the convenience of your home office. You will be responsible for preparing, reviewing, and submitting regulatory documentation to health authorities worldwide, ensuring compliance with evolving regulations. This role is critical in navigating the complex regulatory landscape to bring vital medicines to market efficiently and effectively. The ideal candidate will have a comprehensive understanding of regulatory strategies, submission requirements, and post-approval activities. You will collaborate closely with internal teams, including R&D, Quality Assurance, and Commercial, as well as external regulatory agencies. We are committed to building a strong, collaborative remote team culture, providing the necessary tools and support for success. Your expertise will be instrumental in shaping our regulatory pathway and ensuring patient access to innovative therapies.

Key Responsibilities

• Develop and implement regulatory strategies for new drug applications (NDAs), marketing authorization applications (MAAs), and other regulatory submissions.
• Prepare, review, and manage the compilation of high-quality regulatory submission documents (e.g., CTD modules, INDs, supplements).
• Liaise directly with health authorities (e.g., SAHPRA, FDA, EMA) on submission requirements, deficiencies, and approvals.
• Monitor and interpret global regulatory guidelines and advise on their impact on company products and strategies.
• Manage post-approval activities, including annual reports, variations, and lifecycle management.
• Ensure that all regulatory documentation and activities are compliant with relevant regulations and internal policies.
• Collaborate with cross-functional teams to gather necessary information for submissions and respond to regulatory inquiries.
• Contribute to the development and maintenance of regulatory databases and tracking systems.
• Provide regulatory guidance and training to internal stakeholders.
• Participate in regulatory inspections and audits as needed.
• Stay informed about emerging regulatory trends and best practices.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs, with a focus on global submissions.
• Proven experience in preparing and managing major regulatory submissions (e.g., NDAs, MAAs, ANDAs).
• Thorough understanding of regulatory requirements in key markets (e.g., South Africa, US, Europe).
• Experience with eCTD publishing software and regulatory information management (RIM) systems.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines in a remote environment.
• Strong analytical and problem-solving skills.
• Demonstrated ability to collaborate effectively with cross-functional teams.
• Proactive and adaptable with a commitment to continuous learning.

Benefits

• Our client offers a competitive salary, comprehensive medical aid, and a performance-based bonus structure.
• This remote role provides exceptional flexibility and work-life balance.
• Employees benefit from opportunities for professional development, including training programs and conference attendance.
• Career advancement opportunities within a growing global company are significant.

You will be part of a mission-driven organization dedicated to improving healthcare outcomes.