How you’ll spend your day
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 guidance's 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 guidance 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.
Your experience and qualifications
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
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.
