BE - Regulatory Affairs Officer / Submission Publisher

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

GENERAL SCOPE OF WORK:

The General Scope of Work will include publishing regulatory submissions in eCTD (Electronic Common Technical Document), NeeS (Non-eCTD Electronic Submission) and Paper formats and submitting them according to US and EMEA-Emerging Markets requirements to the respective health authorities (HA) and/or to the Local Operating Companies (LOC). Depending on the assigned submission(s), required activities may include, but may not be limited to:

Dossier Planning & Publishing Responsibilities:

• Perform submission publishing activities in eCTD and non-eCTD format across US and countries within the EMEA-Emerging Markets (EM) region according to applicable Health Authority (HA) and dossier formats.
• Utilize current electronic document management and publishing tools to assemble, publish, validate and dispatch dossiers via electronic HA gateways or portals, or according to the regional regulatory requirements for paper and electronic formats.
• Perform QC of electronic and paper submissions to ensure compliance with HA and internal requirements, guidelines, and processes.
• Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable.
• Maintain openly, timely and effective communications with all contributors and responsible RA professionals to ensure timely delivery of dossier for submission.

Education & Experience Requirements:

• University/Bachelor's degree or equivalent experience in the pharmaceutical industry or related experience.
• Experience in submission publishing processes and leading tools is preffered with specific experience in Liquent Insight Publisher and ISI Publisher tools.
• Proficiency in applying submission-readiness and publishing standards via Adobe Acrobat, MS Word, PDF and related applications.
• In-depth knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines.
• Demonstrated ability to build productive relationships across an organization required.
• Problem-solving capability, including trouble shooting and adaptability required.
• Understanding of the drug development process.
• Fluency in English.

EXTRA INFORMATION:

• Flexible working hours.
• Because of COVID-19, you will work fulltime from home.
• This is a long term contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Ausy. Ausy can offer you a contract of indefinite duration, a project contract for the duration of the assignment at J&J or a freelance contract.