Teva Manager Regulatory Affairs 

United States, Pennsylvania, East Bradford Township 

759157585

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.

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.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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