Provide proactive and practical regulatory affairs guidance and strategies to achieve the required authorisations for CTA's in the EU/RoW regions.
Participate as an active member of a multi-disciplinary clinical team to establish regulatory strategies for the clinical trial applications for the development programs. Identify and communicate potential risks associated with strategy scenarios
Responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
Regulatory affairs activities with particular focus on regulatory compliance for clinical trials
To communicate progress and identify risks and issues arising on regulatory issues to Regulatory Affairs management and the cross-functional Development Clinical Trial Team
Management and oversight of the regulatory activities with the CROs to ensure quality regulatory submissions
Responsible for submission of the CTAs directly to Health Authorities, or manage and oversee the CTA submission with the CRO
Identifies and proactively responds to issues, problems, or opportunities as it relates to the management of the CRO
Contribute to a range of project teams, as required
Manage organising and scheduling teamwork to ensure that projects meet agreed regulatory procedural deadlines
Provide in-depth reviews of protocols, reports, presentations and documents
Coordinate preparation and review of clinical trial applications, amendments, responses to Agency questions.
Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
Manage timelines to ensure approvals are timely and development objectives are met
Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
Provide risk assessments and recommendations for various regulatory scenarios
Participate in the electronic review and quality verification of regulatory submissions
Develop SOP’s and work instructions to ensure consistent ways of working within the regulatory department
Be a focal point and lead internal audits and external GCP inspections, as appropriate
Bachelors or Masters or advanced degree in a scientific discipline, with 8-10 years of increasingly responsible regulatory experience in the pharmaceutical industry
Demonstrated understanding and strategic application of regulations and guidelines for drug development
Knowledge of Development Good Practices (GxP).
Excellent English verbal and written communication skills
Exceptional communication, collaboration and influencing skills.
Leadership ability within a team environment
Ability to work with limited supervision, attention to detail, set priorities to meet timelines and to motivate and influence others
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators