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Regulatory Affairs Associate III - 1436

Date: Jan 11, 2019

Location: Frazer, Pennsylvania, US, 19355

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

The CMC Regulatory SRC Associate partners with the CMC Regulatory Leads within the Specialty Regulatory Affairs organization to ensure high-quality CMC submissions are prepared for handoff for submission.  Activities include being the SME (subject matter expert) for all formatting, TACT Authoring Templates, SAGE (Electronic Documentation Repository) and global industry-standards relating to CTD, eCTD document management. 

 

Major Duties and Responsibilities

 

  • Identify, establish, and continuously re-evaluate, efficient SRC business processes across the organization to ensure high-quality CMC documentation is ready for handoff to the Regulatory Operations team for submission.
  • Ensure internal departmental business processes, including communication, coordination and prioritization of activities, are optimized to address high volume activities and/or highly complex submissions.
  1. Provide submission support to all Specialty CMC Regulatory Leads as well as to other departments’ CMC Submission Managers/Authors, including, but not limited to:
  2. Setting up submissions in SAGE based on the timeline and content plan provided by CMC Leads.
  3. Liaising with R&D department Submissions Managers to ensure clarity on the business process to be followed
  4. Ensuring efficient use of Virtual Documents(VRDs) and adding/removing submission documents from the VRD as needed.
  5. Guiding authors on submission format of documents, as needed, to meet the SRC guidelines, reviewing proposed documents and ensuring they are submission-ready.
  6. Publishing drafts of submissions, as needed to help facilitate review and approval of CMC content
  7. Addressing questions from authors pertaining to TACT and SRC requirements.
  8. Participate in cross-functional project team meetings to assist with the authoring process, communicating issues, and proposing solutions.
  9. Proactively assess work load and maintain open line of communication with CMC leads.
  10. Proactively assess changes in industry electronic submission practices impacting CMC from a global perspective.
  11. Assure adherence to global regulatory requirements as they pertain to document creation, linking, organization, format, and other standards.
  12. Assist in the evaluation of new software that impacts the tools used to author, manage, view and track CMC regulatory submissions..
  13. Manages the Quality Folder structure in SAGE This includes managing all dictionaries to support CMC submissions and tracking and organizing documents in CTD format.

May provide training on the use of templates, authoring environment and publishing technologies and processes to CMC sites as needed

Qualifications

  1. Undergraduate degree or equivalent industry experience.
  2. Eight years of pharmaceutical industry experience, including three years of regulatory publishing.
  3. Knowledge of document management technology and electronic publishing.
  4. Knowledge of preparing eCTD submissions.
  5. Understanding of global Module 2 and 3 submissions, content and regional CMC requirements
  6. Familiar with Documentum, eCTD publishing tools, eCTD Viewing Tools, Regulatory Document Formatting Standards. 
  7. Skilled in using desktop applications; proficient in computer systems and procedures.  Knowledge of Adobe-Toolbox, Microsoft Word, Excel, and PowerPoint.
  8. Ability to interact with, and influence deliverables from, many different R&D and Operations organizations that do not fit ideal submission model, and that may operate outside the Specialty R&D environment.
  9. Able to adapt to fluid environment with prioritization changes driven by the needs of the Specialty Pharmaceutical organization.
  10. Good interpersonal, communication and organizational skills.
  11. Ability to work under pressure and meet critical deadlines.
  12. Excellent team building abilities.
  13. Pays strict attention to detail to ensure documentation is submission ready.
  14. Skilled in managing multiple projects.
  15. Good understanding of global regulatory requirements.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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