Regulatory Affairs Consultant

Description

• Strategic and operational contact with Global Clinical and Regulatory Affairs, and manufacturing sites, in regards to submissions and approvals of new registration or life-cycle maintenance applications including clinical trial activities, if assigned in EURMEA.
• Strategic and operational key life-cycle maintenance of marketing authorisations in the EU, which are approved through the Centralized (CP), Mutual Recognition (MRP) and Decentralized (DCP) procedures. Driving the business forward with key cycle enhancements.
• Preparation and submission and regulatory approval of assigned projects within regional EURMEA as required, including liaison with Middle East, Africa and CIS countries.
• Strategic and operational interaction with Heads of Regulatory Departments in the Europe, CIS, Middle East and Africa as required.
• Driving strategic vision projects in the Region, including implementation of the value reporting model for Regulatory Affairs.
• Regulatory intelligence related to the pharmaceutical eye care industry. Monitor developments in EU legislation and guidelines applying to pharmaceutical products in the EU and implement for products approved in the EU through the Centralized (CP), Mutual Recognition (MRP) and Decentralized (DCP) procedures.
• Build relationships with EURMEA business and develop a culture of innovation and continuous improvement including developing new processes in EURMEA

• Sound understanding of the phases, processes and techniques used within a drug development environment including protocol design and development.
• Understands, and can apply appropriate Competent Authority regulations and guidelines.
• Understanding and ability to apply good clinical practice (GCP).
• Working knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as they apply to a pharmaceutical research and production environment.
• Experience in all EU registration filings routes (CP, MR, DCP and National routes)
• Demonstrates problem-solving and interpersonal skills through effective interactions with team members and generates alternative solutions prior to elevation of issues to manager.
• Knowledge of team dynamics and ability to function as project leader.
• Ability to function with a good level of independence.
• Excellent written and oral communication skills
• Technical Leadership skills/understanding of managing and coaching people
• High Energy level, self-motivated with drive and passion to meet business objectives and deadlines.
• Travel as required by role

• Life science degree or other relevant education.
• At least 6 years of relevant experience of a broad range of regulatory work, especially in the EU, in the ethical pharmaceutical industry.