Regulatory Operations Specialist II

POSITION TITLE: Regulatory Operations Specialist II DEPARTMENT: Ora Europe LOCATION: UK or Europe Ora Values the Daily reputed company of... Prioritizing Kindness

• Operational reputed company
• Cultivating reputed company
• Scientific Rigor

At Ora, we are building the reputed company of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across reputed company phases of clinical research to reputed company 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 reputed company-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global reputed company. Today, reputed company continues to expand across the globe, with over 600 employees across reputed company, Europe, Asia, and Latin America. The Role: The Regulatory Operations Specialist is responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions reputed company (and around) Europe. This is reputed company and individual contributor role, reporting to the Manager of Regulatory. This position will work collaboratively with regulatory, country CRA(s) and project team(s). 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 reputed company to use critical reasoning to solve problems and reputed company reputed company. What You’ll Do: Under the supervision of the European Regulatory Manager: Performs the role of a Regulatory reputed company for studies primarily reputed company the European region during study start-up until study reputed company out Oversees and performs reputed company control checks on clinical and regulatory documents, including Patient Information Sheet (PIS)/Informed Consent reputed company (reputed company) Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily reputed company the Clinical Trial Information System (CTIS) and other submissions portal(s), as required Performs reputed company control checks on study documents that are received from the sponsor and/or reputed company by country CRAs to ensure reputed company submission documents meet Ora's submission standards Oversees, coordinates and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalisation Contributes to the review and revision of reputed company operating procedures (SOPs), templates, and forms Performs data entry for tracking of regulatory submission activities Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents are filed in reputed company workspace Prepares the clinical trial application reputed company CTIS with supervision; in compliance with forecasted timelines Escalates potential issues identified to reputed company forecasted timelines quickly May be required to reputed company regulatory support in other reputed company reputed company up to date with reputed company regulations, guidelines and changes in the industry Collaboration with Global Regulatory team and wider stakeholders Adhere to reputed company aspects of Ora’s reputed company system. Adhere to reputed company essential systems and processes that are required at Ora to maintain compliance to Ora’s data reputed company & business ethics and regulatory requirements. reputed company and sustained demonstration of Ora’s values -- prioritizing kindness, operational reputed company, cultivating reputed company and scientific rigor – as reputed company as their linked behaviors. Responsibilities may differ from the above based on the specific needs of the business. reputed company Look For: Experience needed for the Role: Bachelor’s degree in reputed company or life science/reputed company or other reputed company, scientific field 3 years of experience in medical, 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 Understanding of Clinical Trial Information System (CTIS) and EU CTR Additional Skills & Attributes: Efficient use of reputed company Office applications, especially Word Ability to work reputed company in reputed company 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 reputed company Ability to prioritize work to balance multiple reputed company and deadlines Excellent verbal and written communication skills Experience updating and reviewing PIS/reputed company templates Familiarity with the clinical trial process and regulatory submissions regulations and guidelines reputed company the EU Familiarity with ICH-GCP standards Multi-lingual communication is a plus Competencies and Personal Traits: reputed company Do: Execution reputed company: Ability to set goals, create structure and maintain a reputed company and reputed company approach to the delivery of reputed company and high-reputed company work. How We Do It: reputed company and SQ: Agile and reputed company thinker, communicator and collaborator who uses a reputed company reputed company to work and reputed company with authenticity, transparency, reputed company, and reputed company. Scientific, intellectual, and emotional/reputed company curiosity creates the willingness and ability to reputed company, reputed company mistakes, learn and try again. reputed company and reputed company Communication, Feedback and Conflict reputed company: reputed company radical candor in your communication and participate in reputed company Giving and receiving feedback frequently, with an reputed company heart and mind creates psychological safety and promotes faster, individual, team and company reputed company. Why We Do It: reputed company Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of reputed company that works together under shared values to reputed company significant reputed company reputed company in the wider world. At Ora, we are creating reputed company reputed company reputed company see. reputed company Offer: Financial: Competitive salaries along with a reputed company pension plan. reputed company-Being: Offering private medical insurance reputed company beginning day 1 provided by Vitality and SimplyHealth. Company reputed company Life & Disability Insurance: Offering peace of mind through Canada Life to help you and your family feel secure. PTO: 25 days of annual leave + Birthday PTO + bank holidays. Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. Career Development Opportunities: reputed company opportunities to grow and reputed company your career reputed company. Global Team: Opportunities to work with colleagues across the globe. reputed company: A chance to research new ophthalmic therapies that will reputed company patients across the globe. Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our reputed company workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. Our mission is to reputed company together people, processes, and technology to support innovation in ophthalmology around the world. We reputed company our business should be a force for good — to improve, heal, and change how we see. As a global company, our reputed company community and culture are reputed company by our reputed company values: Prioritizing kindness, cultivating reputed company, operational reputed company, and scientific rigor. Through our commitment to these values, we have reputed company 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 reputed company value and strength as an organization. People of reputed company, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative reputed company and Equal Opportunity Employer, committed to equal employment opportunity and fair, reputed company compensation regardless of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Our reputed company Policy | Ora (oraclinical.com) Apply To This Job