Regulatory Affairs Officer

Company Description RUDIPHARM LIMITED is a pharmaceutical company committed to delivering safe, effective, and high-quality medicines to patients and healthcare providers. The organization focuses on rigorous standards throughout the product lifecycle, from development to distribution. RUDIPHARM LIMITED values integrity, scientific excellence, and compliance with all applicable regulations and guidelines. Team members work in a collaborative environment that supports professional growth and continuous improvement.

The company encourages innovation while maintaining a strong emphasis on patient safety and ethical practices.

Role Description The Regulatory Affairs Officer is a full-time, on-site role based in Watford. This role is responsible for preparing, reviewing, and managing regulatory documentation to support product registrations, renewals, and variations. The Regulatory Affairs Officer will coordinate regulatory submissions to relevant authorities, ensure compliance with current regulatory requirements, and monitor changes in legislation and guidelines. Daily tasks include maintaining regulatory databases, supporting cross-functional teams with regulatory advice, and contributing to internal audits and inspections.

The role also involves collaborating with quality, manufacturing, and commercial teams to ensure product information, labeling, and promotional materials meet regulatory standards.

Qualifications

• Demonstrated skills in Regulatory Documentation and Regulatory Submissions for pharmaceutical or related products.
• Strong knowledge of Regulatory Compliance and Regulatory Requirements within the applicable markets.
• Experience in Regulatory Affairs, including interaction with regulatory authorities and preparation of dossiers.
• Relevant degree in pharmacy, life sciences, chemistry, or a related discipline.
• Excellent attention to detail, organizational skills, and ability to manage multiple projects and deadlines.
• Clear written and verbal communication skills, with the ability to present complex information accurately.
• Proficiency with standard office and documentation software; familiarity with regulatory databases is an advantage.
• Prior experience in a pharmaceutical or healthcare setting and knowledge of EU/UK regulatory frameworks is beneficial.