Remote Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is seeking a dedicated and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This position is crucial for ensuring that our client's pharmaceutical products meet all necessary regulatory requirements for market approval and compliance worldwide. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This role offers the chance to work autonomously and contribute significantly to global drug accessibility, collaborating with internal and external stakeholders in a dynamic, remote-first environment.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations) to health authorities in various global regions.
• Interpret and apply complex regulatory guidelines and ensure adherence throughout the product lifecycle.
• Act as a key point of contact with regulatory agencies, responding to queries and facilitating communication.
• Monitor and analyze changes in the regulatory environment and assess their impact on company products and strategies.
• Collaborate with R&D, Quality Assurance, and Commercial teams to ensure regulatory requirements are integrated into product development and lifecycle management.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.

Requirements

• Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Life Sciences, Chemistry).
• Minimum of 5 years of experience in pharmaceutical regulatory affairs .
• Strong understanding of global regulatory submission processes and requirements (e.g., FDA, EMA, MHRA).
• Experience in preparing and filing various types of regulatory dossiers.
• Excellent written and verbal communication skills, with a strong ability to convey complex information clearly.
• Proficiency in regulatory information management systems and document control.

Benefits

• A competitive annual salary package.
• Comprehensive medical, dental, and vision benefits.
• Flexible working hours and the ability to work from anywhere within approved regions.
• Dedicated budget for professional development, conferences, and training in regulatory affairs .
• Supportive virtual team environment focused on collaboration and success.