Share this Job

Manager-Global Specialty Regulatory Affairs, Systems and Procedures

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

Ensures that global procedures (SOP, WI and Best Practices) relevant to Global Specialty RA are created as identified, managed according to established DMS, and accessible to staff as needed. Ensures that a Specialty RA training program is maintained at the local/regional level, including review and maintenance of curriculum and entry of curriculum into all relevant LMS as needed. Liaises with other functional groups (e.g. Clinical Development, Clinical Operations, PV, R&D CMC), to ensure alignment of responsibilities as required for compliance to regulations. Demonstrates a thorough understanding of health authority guidelines, as well as a strong understanding of regulatory and quality management processes that apply to clinical drug development and manufacturing. Provide systems-based support, using relevant metrics principles, for Specialty team systems that are considered business-critical, including submission preparation, review and tracking tools.

  • Manages Global Specialty RAs procedures system (SOPs, Work Instructions, Best Practices), including processing through established DMS (where applicable), non-content review (formatting, level of detail, consistency with other procedures), and monitoring of periodic reviews. Acts as SME for Global Specialty RA procedure writing and process development.  Interfaces with Global Specialty RA groups to explore/address training and procedure needs, and support authoring activities. 
  • Establishes and administers relevant learning management program for Global Specialty RA including:
    Curriculum creation, review and entry into LMS
    . Works with Specialty RA authors and managers to develop appropriate learning curricula
  • Support Specialty RA systems; assess business processes, identify issues and opportunities for optimization, and support staff training and usage

Qualifications

Bachelor’s Degree in a science or engineering field

3-5 years of Regulatory and/or Quality Assurance Experience

Experience in pharma Regulatory Affairs, and experience working with procedures management programs

Experience with EDMS systems, Microsoft Office suite, Adobe, and Documentum

Understanding of procedure management and learning management systems

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

Find similar jobs: