Regulatory Affairs Publishing Consultant - EU Submissions

Are you an experienced Regulatory Publisher who is an expert in European submission requirements? Who is looking to combine your publishing expertise with your passion for delivering on time quality submissions? Who is looking for an opportunity to partner with a client with innovative therapies and provide oversight to their submissions? Who is looking for an opportunity work from home? Who has superior interpersonal skills and enjoys establishing and maintaining internal and external relationships? Who is savvy with Veeva or Insight Publisher? And is looking for an opportunity work alongside some of the Industry’s best? If you answered ‘yes’ to these questions, Parexel Consulting's growing Team has an excellent opportunity for you!

We currently have an amazing opportunity to join Parexel's Consulting Team as a Regulatory Affairs Publishing Consultant.

In this role you will:Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC.As a global submissions’ expert, ensure the project team has awareness and knowledge of e‑submissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, NDA, MAA, PIP, etc.), updates, amendments, and variations to global regulatory agencies. Manage activities of the publishing related teams in preparation of high-quality submission packages and their timely delivery to health agencies Assures the work of the entire team or work stream is delivered on time and that it meets client’s and Parexel’s quality expectations; functions as the main client contact and ensures accurate project reporting is in place; ensures that appropriate risk identification and issue-escalation procedures are in place; ensures project specific training compliance of the project team; ensures and/or manages project financials including provision of accurate revenue forecast; and ensures that the project team understand and work to the scope of the contract.Compile regulatory submissions. Coordinate distribution of submissions to all concerned parties within agreed upon timeframes. Manage submission and product life-cycle information.Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements.Act as a subject matter expert for InSight and other systems as neededLead and manage special projects as needed.QualificationsTo ensure success, you will have: Bachelor’s degree in a scientific discipline or systems technology or equivalent4-7 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, CRO, etc) with an emphasis on regulatory publishing Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools. Previous Veeva and/or Insight Publisher experience is required.Extensive knowledge of European Global submission standards with an emphasis on EMA requirements and industry trends for dossier preparation (MAAs, PIPsm CTAs, etc.)Knowledge of CDISC (ADaM, SEND, SDTM)A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.MS PowerPoint skillsExcellent interpersonal and intercultural communication skills, both written and verbalClient-focused approach to work (Quality)Results orientationTeamwork and collaboration skillsConsulting skillsCritical thinking and problem-solving skillsProficiency in local language and extensive working knowledge of the English languageThe ability to travel domestically and internationally up to 10-15%, when appropriate, may be requiredEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.