Regulatory Operations Specialist II

📋 Description

• Responsible for supporting the Regulatory submissions team in quality control, document preparation coordination, management, and submissions within (and surrounding) Europe.

• Acts as a Regulatory Lead for studies mainly within the European region from study initiation to closure.

• Supervises and conducts quality control checks on clinical and regulatory documents, including Patient Information Sheets (PIS) and Informed Consent Forms (ICF).

• Responsible for and actively involved in the preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS) and other submission portals as necessary.

• Executes quality control checks on study documents received from sponsors and/or prepared by country Clinical Research Associates (CRAs) to ensure all submission documents comply with Ora's submission standards.

• Coordinates and contributes to the development of country-specific study documents, ensuring sponsor approval prior to finalization.

• Participates in the review and revision of standard operating procedures (SOPs), templates, and forms.

• Performs data entry for tracking regulatory submission activities.

• Updates tracking logs and databases, ensuring that country-adapted and sponsor-approved study documents are filed in a collaborative workspace.

• Prepares the clinical trial application within CTIS under supervision, adhering to projected timelines.

• Quickly escalates any potential issues that may impact projected timelines.

• May be required to provide regulatory support in other regions.

• Stays informed about current regulations, guidelines, and industry changes.

• Collaborates with the Global Regulatory team and other stakeholders.

• Complies with all aspects of Ora’s quality system.

• Abides by all essential systems and processes required at Ora to maintain compliance with data integrity, business ethics, and regulatory requirements.

⛳️ Requirements

• Bachelor’s degree in a relevant applied or life science/healthcare field or other related scientific disciplines.

• A minimum of 3 years of experience in medical, regulatory, or clinical roles, or equivalent training and work experience, including relevant coursework.

• Experience in clinical research, including overseeing or making submissions in a specific country or region.

• Understanding of the Clinical Trial Information System (CTIS) and EU Clinical Trial Regulation (CTR).

• Proficient in using Microsoft Office applications, particularly Word.

• Ability to thrive in a team environment, demonstrating a strong commitment to task completion, adherence to procedures, and the initiative to identify improvement opportunities, alongside interpersonal skills that promote constructive problem-solving.

• Capability to perform well in a fast-paced environment.

• Strong attention to detail with a focus on accuracy and quality.

• Ability to prioritize tasks to manage multiple projects and deadlines effectively.

• Excellent verbal and written communication skills.

• Experience in updating and reviewing PIS/ICF templates.

• Familiarity with the clinical trial process and regulatory submission regulations and guidelines within the EU.

• Knowledge of ICH-GCP standards.

• Multi-lingual communication skills are considered a plus.

🏝️ Benefits

• Competitive salaries along with a structured pension plan.

• Provision of private medical insurance healthcare starting from day one, provided by Vitality and SimplyHealth.

• Offering peace of mind through Canada Life to ensure security for you and your family.

• 25 days of annual leave plus Birthday PTO and bank holidays.

• Reimbursement to support your remote workspace and wellness expenses.

• Ongoing opportunities for career growth and development.

• Opportunities to collaborate with colleagues globally.

• A chance to research innovative ophthalmic therapies that will positively impact patients worldwide.