With a deeply experienced leadership team who possess an outstanding track record of developing innovative clinical assets, our client already has four assets in clinical development and is building the next generation biotechnology company.
Reporting to SVP Regulatory Affairs, United States, the person appointed to this newly created role will be responsible for European Regulatory Operations and for implementing the global regulatory strategy to secure and maintain market access for the assigned product through all development phases.
The Director will be responsible for overseeing the preparation and submission of correspondence and applications to National Competent Authorities (NCA) within the European Union and serve as direct liaison with NCA/EMA to facilitate the prompt review and approval of clinical trial and marketing authorization applications, as warranted.
- Ensuring preparation of high-quality regulatory submission documents, including CTAs, DSURs, IMPDs, and substantial amendments, liaising with the EMA and other regulatory agencies, managing preparation for and attendance at assigned meetings and assisting with responses to queries.
- Leading the authoring of regulatory communications such as regulatory briefing packages, applications for Orphan Drug Designation, Pediatric Investigational Plans, PRIME designations, etc.
- Keep pace with the evolving European legislative and policy landscape and understand how this stands to impact the organization achieving its strategic corporate objectives. This includes monitoring, analyzing, and disseminating intelligence on European regulatory policy and guidelines and make recommendations for impact to projects or organizational practices.
- Inform and advise internal stakeholders on dynamics and trends across the broad range of European and (where appropriate) national level legislative and policy topics, including HTA, that stand to impact market access initiatives.
- Mentor junior regulatory affairs team members, if applicable.
- Assist with regulatory budget for European department and report status to department head.
- Maintain European SOPs for department and prepare EudraCT postings for clinical studies,
- Bachelor’s degree in scientific discipline; advanced scientific degree preferred.
- 12+ years’ pharmaceutical industry experience, including 8+ years in Regulatory Affairs.
- Experience attending and leading a team to prepare for NCA, EMA/CHMP, COMP, and PDCO meetings is required
- Ideally have experience attending and participating in CRO bid defenses for global clinical trials.
- Knowledge and understanding of global development and previous experience with other authorities (FDA, Health Canada) is desirable
- Experience in analyzing and developing regulatory strategies for clinical development of NCEs and Biologics and implementation of regulatory strategy within European countries.
- Experience in multiple phases of development in various therapeutic areas.
- Demonstrated experience in overseeing European regulatory filings for large multinational clinical trials (CTA).
- Demonstrated experience in leading MAA submissions.
Knowledge, Skills and Abilities
- Knowledge of the drug development process and submission process (e.g., GCP & eCTD).
- Expert knowledge of European regulations and guidelines.
- Knowledge of regulatory requirements as they relate to the overall global regulatory strategy.
- Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
- Domestic and/or International travel may be necessary (30%)
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