Senior Associate/Manager - Regulatory Affairs Submissions Operations

Job Description Vertex Pharmaceuticals is seeking an experienced, Regulatory Operations professional who can assist with a variety of submissions and operational activities with limited supervision.

Requirements:

• 5+ Years of eCTD publishing experience (global eCTD filing experience preferred).
• Responsible for both Submission and Document Level Publishing.
• Experience with CTA submissions desired.
• Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, CTAs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
• Knowledge of health authority procedures/guidance's regarding electronic submissions required.
• May interface with project managers, regulatory product managers, and or content authors to discuss routine and non-routine submission preparation.
• Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
• Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
• Liaise with functional source areas to ensure documents are compliant and submission ready. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
• Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
• Minimum Qualifications

   

• Bachelor’s Degree
• 5+ Years of eCTD publishing experience (global eCTD filing experience preferred).
• Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic.
• Knowledge of industry trends regarding electronic submissions.
• Proficiency with MS-Office Suite and Adobe Acrobat applications.
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Excellent organization, written/verbal communication, and attention to detail
• Knowledge of health authority procedures/guidance's regarding electronic submissions.
• Knowledge of Electronic Document Management Systems.
• Ability to balance multiple tasks to meet priorities and timelines.
• Strong attention to detail.
• Company Information

   

  Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. 
  
  Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com. 
  
  Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

  Req ID

   

  11059BR