Senior Director, Regulatory Affairs CMC , Innovative Medicine (Hybrid)

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Senior Director, Regulatory Affairs CMC is responsible to manage and help develop regulatory strategies to support development of innovative products, as well as to ensure efficient management of approved and marketed products.

As the Senior Director, Regulatory Affairs CMC (Innovative Medicine) you will:

• Influence the strategy and assess  the quality of documents for regulatory submissions to major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for global registration. 
• Identify and evaluate CMC issues associated with product development including product and process development, device development, analytical methods, formulation development, manufacturing, and labeling.   
• Manage the process of maintaining and updating of CMC sections of submissions for Teva products, and for ensuring the quality of CMC response to global health authorities.  
• Interface with development, analytical, quality and manufacturing groups across the Teva network, as well as with internal regulatory departments. 
• Manage cross functional product teams for CMC specific projects and contribute to the planning and conduct of meetings with FDA.

Occasional travel required (10% National / International)

Location: West Chester, PA (Hybrid Schedule)

RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS AVAILABLE

How you’ll spend your day

• Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidances and directives, and evaluating and communicating their applicability to the development teams. 
• Develop and communicate effective CMC regulatory strategies for development and post marketing submission activities. Determine and communicate appropriate risk analyses and timeline development.
• Coordinate, author and review the CMC sections of IND, NDA and CTA filings.  Compile and review CMC regulatory documents, including but not limited to Development Reports, Validation Protocols and Reports, NDA supplements, IND and NDA 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 Europe, Israel, Canada and Rest of World assisting with preparation of complete registration dossiers to be submitted to foreign Health Authorities. 
• Lead the review of internal CMC controlled documentation including but not limited to standard operating procedures, test methods, specifications and protocols  
• 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.

Your experience and qualifications

Required:

• Bachelor's Degree in a scientific-related field from an accredited college or university.
• 10 years of pharmaceutical industry experience
• 6 years of Regulatory Affairs experience.

Preferred:

• Advanced degree ( MS, Ph.D. or PharmD)
• Relevant technical experience in Analytical (QC, Analytical R&D), process/product development, or manufacturing
• Knowledge of FDA and ICH Regulatory guidelines
• Experience with eCTD regulatory filings
• Knowledge of U.S. and global content and regional requirements
• Knowledgeable in drug development processes and life cycle management of products

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance

Reports To

VP, Global Regulatory Affairs

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