Remote Regulatory Affairs Specialist - Pharmaceutical

About the Role

Our client is seeking a seasoned Remote Regulatory Affairs Specialist to join their global pharmaceutical team. This critical role involves managing the regulatory submission process for new and existing pharmaceutical products across various international markets. You will ensure compliance with global regulatory standards, interpret complex regulations, and develop effective regulatory strategies. This is a fully remote position, offering flexibility and the opportunity to work from anywhere while contributing to bringing essential medicines to patients worldwide from your home office, ideally based near Welkom for occasional team collaboration if needed.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, MAA) to health authorities globally.
• Interpret and apply international pharmaceutical regulations, guidelines, and standards to ensure product compliance.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Liaise with regulatory agencies, respond to queries, and manage post-approval changes and submissions.
• Collaborate with internal departments, including R&D, manufacturing, and quality assurance, to gather necessary information for submissions.
• Stay abreast of evolving regulatory landscapes and advise the organization on potential impacts.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 4-6 years of experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU, SA).
• In-depth knowledge of regulatory submission requirements and guidelines (e.g., ICH, FDA, EMA).
• 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 setting.

Benefits

• Highly competitive remote salary and potential for performance bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous home office stipend and technology support.
• Significant opportunities for professional development and career growth within a global organization.
• Flexible working hours to accommodate personal needs, ensuring a healthy work-life balance.