Director, Regulatory Affairs CMC (Biologics, Combination Products)

Teva Pharmaceuticals • West Chester, IA

17d

About The Position

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.Our Team, Your ImpactPosition Summary: The Director, Regulatory Affairs CMC is responsible to develop regulatory strategies to support development of innovative molecules and combination products, as well as to ensure efficient management of approved and marketed products.  The responsibilities of the role include compiling, organizing, and assessing documents for regulatory submissions to major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for global registration.
The Director, Regulatory Affairs CMC is responsible for identifying and evaluating CMC issues associated with molecule development products including product and process development, device development, analytical methods, formulation development, manufacturing,  and labeling.  The Director, Regulatory Affairs CMC is also responsible for maintaining and updating CMC sections of submissions for Teva products, and for ensuring the quality of CMC response to global health authorities.  The individual will interface with development, analytical, quality and manufacturing groups across the Teva network, as well as with internal regulatory departments. The Director, Regulatory Affairs CMC will lead cross functional product teams for CMC specific projects and contribute to the planning and conduct of meetings with FDA.

Requirements

• Bachelor’s degree required, preferably in scientific discipline.
• A minimum of 8 years of pharmaceutical industry experience.
• A minimum of 5 years of Regulatory Affairs experience

Nice To Haves

• Advanced degree ( M.Sci., Ph.D., PharmD) is preferred.
• Relevant technical experience in Analytical (QC, Analytical R&D), process/product development, or manufacturing is preferred.
• 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
• 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
• Exceptional interpersonal, communication and organizational skills.

Responsibilities

• 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.

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees