Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to: evaluate Change Requests/Change Controls and provide accurate regulatory assessments for changes impacting applications in development such as INDs and CTAs, submitted but not yet approved applications, and approved BLA applications. Assist to upkeep regulatory tools like standard procedures, authoring guides, position papers, and templates. Communicate Health Authority communication to SMEs within the organization and archive communication per standard practice. Review guidances and regulations for regions within scope of assigned projects. Train on internal SOPs and Work Instructions, and create and utilize job aids and reviewing tools as required. Assist in compiling, authoring, and reviewing applications such as INDs, IMPDs, and BLAs, associated unsolicited pre-approval changes, post-approval changes, and address requests for information. Perform evaluation of change in conjunction with previous health authority feedback and current guidances and regulations. Assist in communicating regulatory strategy to SMEs for applications. Assist in knowledge sharing and matrix training of new employees or new skills. Local telecommuting permitted up to 2 days per week. 5% domestic travel and 5% international travel required.
Minimum Requirements: Bachelor’s degree in Drug Regulatory Affairs, Pharmacy, Biology, Chemistry, or a related field and 2 years of experience in the biotech/pharmaceutical industry in Regulatory Affairs (RA) or a department that works closely with RA including Quality Assurance, Regulatory Compliance, Regulatory Operations, Quality Control, Program Management, or Dossier Development. In the alternative, employer will accept a Master’s degree in the specified fields. Must have biotech/pharmaceutical industry experience with: GXP including cGMP practices; Relevant US FDA Guidance Documents and Code of Federal Regulations; Electronic Document Management Software; Change Control and GMP Systems such as Veeva and Trackwise; Reviewing Technical Documents such as Manufacturing Reports, Validation Reports, or Batch Records; Regulatory Reporting Requirements, Regulatory Assessments and Impact on Implementation; Drug, Biologic, or Biosimilar Development; SOP Training and Additional Work Instructions and Job Aides; eCTD structure, content, organization, navigation, electronic submission process, and minimum document requirements; Navigating and Reviewing Published Regulatory Submission Output; Health Authority Requirements and Standards for Submissions; Communicating with Health Authorities (directly or indirectly); Contributing to Health Authority Applications (directly or indirectly); Authoring and Reviewing CMC content for use in Health Authority Applications; Understanding and communicating CMC Submission expectations to relevant stakeholders and understanding and adhering to expectations from relevant RA stakeholders; Understanding and Communicating assessments to relevant stakeholders/understanding and adhering to assessments from relevant RA stakeholders; Project Management, Submission Management and Change Management; Expectations for Validation/Tech Transfer of Manufacturing DS/DP and/or Testing DS/DP; and, Contributing to Authoring, Review and/or Compilation of submissions to US Applications including INDs, BLAs, NDAs, or ANDAs. Employer will accept 2 additional years of work experience in lieu of the Bachelor’s degree requirement. Employer will accept any suitable combination of education, training or experience. 5% domestic travel and 5% international travel required.
Please apply at https://careers.teva/ and reference job ID 61795. Teva Pharmaceuticals USA Inc. is an EEO/AA employer. No calls.
Skills:
Abbreviated New Drug Application, Biology, Biotech and Pharmaceutical, Change Control, Change Management, Change Requests/Orders, Chemistry, Content Structure, Current Good Manufacturing Practice (cGMP), GxP, Healthcare Software, Insurance Regulations, Investigational New Drug (IND), Manufacturing, New Drug Application, Operations Control, Pharmacy, Position Papers, Procedure Development, Project Estimates, Project/Program Management, Quality Assurance, Quality Control, Regulations, Regulatory Compliance, Regulatory Reports, Regulatory Requirements, Request for Information (RFI), Requirements Management, Software Development, Standard Operating Procedures (SOP), Technical Writing, Willing to Travel
About the Company:
Teva Pharmaceuticals USA Inc.
Our reach is global. Our strategy and leadership are promising and powerful. Our commitment to patients is in the hearts of our employees around the world.
While our global headquarters are located in Israel, Teva's US headquarters are in Pennsylvania, with numerous locations across United States and its territories. Teva's US business operations are among the largest and most progressive presences within the Teva Pharmaceuticals family. We play an essential role in ensuring that Teva medicines are widely accessible not only in the US but throughout the world.
Benefits
We recognize that employees are our greatest asset and take pride in offering a highly competitive, comprehensive, and affordable benefits plan.
Development
Teva is committed to the continual skill development of our employees. While the responsibility for professional development rests with each individual, the Company provides reimbursement of approved tuition and associated eligible expenses up to a defined amount per calendar year. Eligibility for assistance begins after one year of service. Additionally, Teva has a wide range of learning and development resources to support individual growth and career management, including a range of onsite and online offerings, leadership and talent development, and other professional development opportunities.
Teva is a dynamic organization, which creates opportunities for advancement together with the company's growth.
Company Size:
10,000 employees or more
Industry:
Biotechnology/Pharmaceuticals
Founded:
1901
Website:
http://www.tevausa.com/TevaExperience.aspx
