Remote Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; Klerksdorp; Híbrido; ZAR 900.000 - 1.300.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work

Health insurance

Home office stipend

Professional development

International regulatory conferences

Flexible hours

Retirement savings plan

Descripción de la vacante

Placements24 is seeking a Remote Regulatory Affairs Specialist to prepare and submit regulatory dossiers for global drug development. You will work from home, coordinating with authorities such as SAHPRA, FDA and EMA to ensure timely approvals and lifecycle management.

The role requires a strong background in regulatory affairs, with 5+ years in dossier preparation and knowledge of ICH guidelines and eCTD formats. Remote work offers flexibility, with a collaborative, global team environment.

Formación

• 5+ years in pharmaceutical regulatory affairs with dossier preparation.
• Knowledge of global guidelines (ICH, FDA, EMA, SAHPRA) and eCTD formats.
• Ability to work independently in a remote, deadline-driven environment.

Responsabilidades

• Prepare, compile, and submit regulatory dossiers (CTD/eCTD) for drug registrations and lifecycle management.
• Liaise with health authorities (SAHPRA, FDA, EMA) to address queries and manage submissions.
• Ensure all submissions are accurate, complete, and compliant with guidelines and policies.
• Monitor regulatory landscape changes and assess impact on submissions.
• Collaborate with R&D, Quality, Manufacturing, and Legal to gather filing information.
• Provide regulatory guidance and strategic advice to project teams during development.
• Review promotional materials and labeling for regulatory compliance.
• Maintain regulatory databases and track status of submissions and approvals.
• Contribute to SOPs and work instructions within the department.

Conocimientos

Regulatory expertise

Attention to detail

Project management

Documentation & writing

Communication skills

Educación

Bachelor's degree in Pharmacy, Chemistry, Biology or related life science

MSc or PhD in regulatory science or related field

Herramientas

RIM systems

Descripción del empleo

About the Role

Our client, a dynamic and rapidly expanding pharmaceutical company, is seeking a highly skilled and motivated Remote Regulatory Affairs Specialist to bolster their submission team. This is a fully remote opportunity, allowing you to contribute to global drug development from the comfort of your home office. The successful candidate will play a critical role in preparing, submitting, and managing regulatory dossiers for new drug applications (NDAs), variations, and other regulatory filings across various international markets. This position demands a comprehensive understanding of global regulatory landscapes, exceptional attention to detail, and the ability to navigate complex submission processes efficiently. If you are a seasoned regulatory professional seeking a challenging and flexible remote role, this is an ideal opportunity to leverage your expertise and make a significant impact on bringing essential medicines to patients worldwide. Join our client's collaborative and forward-thinking team, working remotely to shape the future of pharmaceutical regulation.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers (e.g., CTD, eCTD) for drug product registration and lifecycle management in accordance with global regulatory requirements.
• Liaise with health authorities (e.g., SAHPRA, FDA, EMA) to address queries, facilitate reviews, and manage the submission process.
• Ensure all regulatory submissions are accurate, complete, and compliant with current guidelines and company policies.
• Monitor changes in the regulatory landscape and assess their impact on current and future submissions.
• Collaborate with internal departments, including R&D, Quality Assurance, Manufacturing, and Legal, to gather necessary information for regulatory filings.
• Provide regulatory guidance and strategic advice to project teams throughout the drug development lifecycle.
• Review promotional materials and product labeling for regulatory compliance.
• Maintain regulatory databases and track the status of ongoing submissions and approvals.
• Contribute to the development and implementation of departmental SOPs and work instructions.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Advanced degree (MSc, PhD) or equivalent regulatory experience is preferred.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs, with a strong focus on dossier preparation and submission management.
• In-depth knowledge of global regulatory guidelines (ICH, FDA, EMA, SAHPRA) and submission formats (eCTD).
• Proven track record of successfully preparing and filing regulatory dossiers for various stages of drug development.
• Excellent analytical, organizational, and problem-solving skills.
• Exceptional written and verbal communication skills, with a keen eye for detail.
• Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines in a remote environment.
• Proficiency in regulatory information management (RIM) systems is a plus.
• Strong interpersonal skills and the ability to build effective working relationships with internal teams and external health authorities.

Benefits

• Competitive salary commensurate with experience and remote work arrangement.
• Comprehensive health, dental, and vision insurance.
• Generous remote work stipend for home office expenses and internet.
• Extensive opportunities for professional development, training, and attending international regulatory conferences.
• Flexible working hours to support work-life balance.
• Retirement savings plan with company match.
• Collaborative and supportive remote team culture.