Senior Regulatory Operations Specialist Remote- Europe

POSITION TITLE: Senior Regulatory Operations Specialist

DEPARTMENT: Ora Europe

LOCATION: UK, Italy or Spain

Ora Values the Daily Practice of

Prioritizing Kindness • Operational Excellence • Cultivating Joy • Scientific Rigor

At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

The Senior Regulatory Operations Specialist is responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within (and around) Europe. This is a team and individual contributor role, reporting to the Manager of Regulatory. This position will work collaboratively with regulatory, country CRA and project team. This position requires a strong technical background, a high degree of enthusiasm, enjoyment of working in a fast-paced environment, being self-motivated, and being able to use critical reasoning to solve problems and make decisions.

What You'll Do:

• Performs the role of a Regulatory Lead for studies within the European region during study start-up until study close out
• Oversees and performs quality control checks on clinical and regulatory documents
• Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS)
• Performs quality control checks on study documents that are received from the sponsor and/or prepared by country CRAs to ensure all submission documents meet Ora's submission standards
• Prepares Master Patient Information Sheet (PIS)/Informed Consent Form (ICF) with supervision
• Oversees, coordinates and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalization
• Contributes to the review and revision of standard operating procedures (SOPs), templates, and forms
• Performs data entry for tracking of regulatory submission documents and activities
• Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents and regulatory approvals are filed in collaborative workspace
• Prepares the clinical trial application within CTIS with supervision; in compliance with forecasted timelines
• Escalates potential issues identified to impact forecasted timelines quickly
• Prepare and deliver training to internal team
• Provide SME guidance and support to internal operational team and external clients
• Provide oversight and guidance to more junior team members
• May be required to provide regulatory support in other regions
• Keep up to date with current regulations, guidelines and changes in the industry
• Collaboration with Global Regulatory team and wider stakeholders
• Adhere to all aspects of Ora's quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora's values prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

What We Look For:

• Experience needed for the Role:
  • Bachelor's degree in applied or life science/healthcare or equivalent
  • 5 years of regulatory, or clinical experience or equivalent training and work experience, including coursework.
  • Experience with clinical research including overseeing or making submission in a country or region
  • Experience with Clinical Trial Information System (CTIS) and EU CTR
• Additional Skills & Attributes:
  • Competency in Microsoft Office applications, especially Word
  • Ability to work well in a team environment, have a strong commitment to the accomplishment of tasks, can follow procedures, and has the initiative to identify opportunities for improvements and the inter-personal skills to promote and accomplish constructive solutions to problems.
  • Ability to work in a fast-paced environment
  • Attention to detail with emphasis on accuracy and quality
  • Ability to prioritize work to balance multiple projects and deadlines
  • Excellent verbal and written communication skills
  • Experience generating and adapting PIS/ICF templates
  • Familiarity with the clinical trial process and regulatory submissions regulations and guidelines within the EU
  • Familiarity with ICH-GCP standards
  • Multi-lingual communication is a plus
• Competencies and Personal Traits:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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