Teva Manager CMC Regulatory Affairs - West Chester PA 

United States, Pennsylvania, East Bradford Township 

740604357

As Manager, CMC Regulatory Affairs you will be responsible for managing the day-to-day chemistry, manufacturing, controls (CMC) regulatory activities for all assigned marketed products, as well as those products that are currently in development. You will be responsible for compiling, organizing, and assessing documents for regulatory submissions to health authorities (e.g., FDA, Health Canada) as well as working with global regulatory colleagues in preparing dossiers for products for global registration. You will be responsible for maintaining and updating CMC sections of submissions for assigned products.

As Manager CMC Regulatory Affairs you will also be responsible for identifying and evaluating CMC issues associated with development products, including product and process development, analytical methods, formulation development, manufacturing, and labeling. You will interface with development and manufacturing groups, as well as with internal regulatory departments, provide for support cross functional product teams for CMC specific projects and may assist in the planning and conduct of meetings with FDA.

Other duties:

• Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the development teams.
• Coordinate, author and review the CMC sections of IND, BLA (351k) and CTA filings. Compile and review CMC regulatory documents, including but not limited to Development Reports, Validation Protocols and Reports, BLA supplements, IND and BLA Annual Reports, and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA.
• Support the global registration initiative for marketed products by liaising with Regulatory counterparts in the Europe, Israel, Canada and Rest of World assisting with preparation of complete registration dossiers to be submitted to foreign Health Authorities.
• Support the review of internal CMC controlled documentation including but not limited to standard operating procedures, test methods, specifications, protocols and reports.
• Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments.
• Assist in planning and conducting meetings with regulatory agencies for routine meetings and interactions.
  

Required Qualifications:

• Bachelor’s degree in Pharmacy, Biology, Chemistry, or other related scientific discipline
• Minimum 5 years of experience in the biotech/ pharmaceutical industry, including 3 years of experience in Regulatory Affairs
• Experience working in matrix teams

Preferred qualifications:

• Advanced degree (MS/PhD in pharmacy, biology, chemistry, pharmacology or related life science, MBA, or MD)
• Minimum 7 years of experience in the biotech/pharmaceutical industry, including 4 years Regulatory Affairs experience
• Experience with biosimilars/biologics
• Experience in technical role in analytical (QC, Analytical R&D) or process/product development, or manufacturing
• Knowledgeable in drug development processes and life cycle management of products
• Familiarity with FDA Regulatory guidelines
• Experience with CTD regulatory filings
• Understanding of global Module 2 and 3 submissions, content and regional CMC requirements
• Clear, concise technical writing skills
• Ability to manage multiple projects and competing timelines
• Ability to assess regulatory requirements and filing timelines in order to judge the work required for submission of a quality filing
• Ability to assess technical quality of documents and to provide regulatory feedback to colleagues
• Ability to respond quickly with reasonable solutions and alternatives to regulatory-related problems
• Good interpersonal, communication and organizational skills

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