Description Regulatory Consultant (Veeva RIM)
Job ResponsibilitiesGRO RPSM - Regulatory Submissions Coordinator Manager
Required Knowledge/Skills
- Create and Maintain Content Plans within Veeva Vault RIM
- Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM
- Assist with planning, managing, and tracking of regulatory submissions
- Support Vertex Global Submission Managers with project management activities, tasks and tracking
- Assist with coordination and communication of regulatory submissions to Vertex Publishing
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
- Excellent organization, written/verbal communication to explain difficult information, and attention to detail.
- Submission Technology: Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems. Keywords: Insight Publisher, Lorenz Publisher, Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox
- Project Management Technology: Experience and proficiency with project management tools and software. Keywords: Smartsheet, Microsoft Project, Excel, Office timeline Pro
Required Education Level & Experience
- B.S. (or equivalent experience) and 5+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions
- M.S. (or equivalent experience) and 3+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions
- In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS
Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Summary Regulatory Submission manager overseeing the submission plans for various products in development and on market products in US/ EU/ and global markets.
