At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

Are you passionate about advancing clinical research through precise and compliant regulatory submissions? We are seeking a dedicated and detail-oriented Senior RA Professional CTA to lead and support clinical trial application submissions worldwide. You will play a vital role in ensuring smooth, on-time filings while collaborating with a dynamic team of stakeholders.

We are searching for the best talent for Sr RA Professional Submissions for Clinical Trial Applications to be in Leiden, NL or Warsaw, PL.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

High Wycombe, United Kingdom – Requisition Number: R-021191

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

In this role, you will:

• Create comprehensive CTA dossier plans and submission packages aligned with clinical trial regulatory strategies, ensuring all documentation is accurate and complete.
• Lead and Facilitate Clinical Trial Submission Team meetings, coordinating efforts across departments to prepare, review, and maintain high-quality regulatory submissions.
• Establish and maintain open, effective communication channels with internal and external stakeholders. Resolve conflicts related to priorities, resources, or timelines proactively.
• Contribute to developing and optimizing operational strategies for clinical trial submissions, balancing project timelines, resources, and compliance requirements.
• Leverage regulatory information management systems to compile, publish, and track dossier submissions according to regulatory authority standards.
• Contribute to departmental process enhancements, develop best practices, and create training materials to promote efficiency and compliance.

Additional Responsibilities:

• Lead or contribute to special CTA-related projects and process improvement initiatives aimed at streamlining CTA submission processes and ensuring regulatory excellence.
• Stay current on evolving global regulatory requirements to ensure submissions meet all necessary standards.

Qualifications / Requirements:

• or equivalent CTA experience with 4-6 years in the pharmaceutical industry or related field.
• A Masters/Pharm D or PhD is a plus
• Proven experience in managing clinical trial regulatory submissions.
• Strong leadership skills with the ability to coordinate cross-functional teams.
• Excellent communication and relationship-building skills.
• Proficiency with regulatory information management systems.
• A proactive mindset focused on continuous improvement and process optimization.