Senior Regulatory Affairs Specialist – Trial Transparency Liaison

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Deliver strategic regulatory insights and guidance to support product development from the preclinical phase through registration and product optimization.

• Create client deliverables that comply with current local, regional, and ICH regulatory and technical standards.

• Serve as a liaison with both internal and external clients to provide and promote regulatory services.

• Lead and manage transparency initiatives at the CTT level, which includes protocol registration, result posting, and the redaction of CTIS documents.

• Assist in IDT-level transparency efforts, encompassing the anonymization and/or redaction of post-marketing approval documents.

• Oversee and coordinate global disclosure and transparency deliverables in line with the company's transparency policy.

• Initiate and maintain clinical trial registration in global trial registries such as ClinicalTrials.gov and CTIS.

• Lead and coordinate the posting of results in global trial registries.

• Manage and coordinate the redaction of CTIS documents, including the identification of commercially confidential information.

• Stay informed on the evolving global regulations regarding transparency and disclosure.

• Provide or lead transparency activities as per direction.

• Prepare and review regulatory submissions.

• Offer regulatory strategy and technical guidance to internal and external clients.

• Spearhead the development and execution of project-specific sponsor processes.

• Collaborate with various departments, regulatory consultants, and regulatory authorities.

• Identify contract activities that are out of scope and coordinate necessary contract modifications.

• Offer training and mentorship to junior team members.

• Participate in project launches, reviews, and project team meetings.

• Support business development efforts, including project budgeting and forecasting.

⛳️ Requirements

• Bachelor's degree or equivalent relevant academic/vocational qualification.

• Previous experience equivalent to 5+ years.

• At least 3 years of experience in clinical trials.

• Experience in transparency roles (protocol registration, CTIS redaction, clinicaltrials.gov) is advantageous.

• Familiarity with global clinical trial transparency regulations.

• Knowledge of clinical trial documents and clinical study and development design.

• Strong written and oral communication skills in English, along with proficiency in the local language where applicable.

• Excellent editorial/proofreading abilities with a keen eye for detail and quality.

• Proficient interpersonal, organizational, time management, planning, negotiation, analytical, investigative, and problem-solving skills.

• Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat Pro.

• Capacity to learn new technologies.

• Ability to work independently and make sound judgments.

• Understanding of global/regional/national clinical trial authorization, licensing, lifecycle management, ICH, and other global regulatory guidelines.

• Familiarity with medical terminology, statistical concepts, and relevant guidelines.

• Working knowledge of budgeting and forecasting.

• Ability to multitask and prioritize effectively in a fast-paced environment.

• Capability to oversee CTT transparency activities.

• High adaptability and intrinsic motivation.

• Willingness to travel occasionally, including domestically and internationally.

• In certain cases, equivalent education, training, and/or directly related experience may be deemed sufficient.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.