The Senior Director II, Global Specialty Products Regulatory Affairs is a strategic leadership role that will be responsible and accountable for the regulatory success of his/her Therapeutic Area (TA).
Essential Duties & Responsibilities
1. TA leadership
2. Strategic influencing
3. Project, asset (in-lic) and budgetary responsibility
4. Provides training and mentorship to regulatory staff.
Independently develops Regulatory Intelligence to support above activities.
5. Follows Teva Safety, Health, and Environmental policies and procedures. 5%
6. Cross-GSP and cross-GSP RA leadership team assignments 5%
Primary Responsibilities
The individual will establish the regulatory strategic direction of the Respiratory/Oncology Therapeutic Area, and will be responsible for the development, coordination and implementation of strategies for regulatory submissions in US, EU and world-wide. The individual will provide regulatory guidance to development teams on proprietary products, will coordinate with Teva’s European regulatory counterparts on EU filings, and will interact with US, European and Global regulatory authorities as needed. The individual will interface with management of Clinical, Non-Clinical, Operations and Marketing departments for new and marketed products, and will assure maintenance of regulatory activities for marketed products. The individual will conduct regulatory assessments on potential licensing and acquisition opportunities.
Travel Requirements
Up to 5% foreign travel (e.g., critical-path meetings, meetings with ex-US Health Authorities, etc) and 10% domestic travel (e.g., meetings with FDA, regulatory conferences, etc) may be required for this position.
Qualifications
Education Required: Bachelor’s Degree in scientific field or equivalent combination of education and related work experience.
Education Preferred: PharmD,, Ph.D., or Master’s degree
Experience Required: 15+ years (or equivalent combination of education and related work experience) of pharmaceutical industry experience in new drug regulated product strategy and submissions; including working knowledge of FDA, EMA, and Health Canada laws / regulations / guidance applicable to registration and approval of drugs or biologics.
Experience Preferred: At least 7 years in regulatory affairs with proven experience (successful filing and defense of major submissions – IND / NDA / BLA / CTA / MAA) setting and executing strategy in pre-clinical, clinical, CMC, or marketed products regulatory; depending on the role of the particular position.
Working knowledge of relevant drug and biologic laws regulations and guidances / guidelines GCPs, GMPs, GLPs.
1. Analysis: Demonstrates the ability to evaluate critical data in order to identify the cause of a problem, seek appropriate expertise, and resolve or facilitate resolution. Thinks through consequences of different courses of action. Exhibits leading edge or novel ways of thinking.
3. Communication:
- Has a strong foundation of communication skills and evolving capacity to learn negotiation skills
- Must be able to effectively communicate with scientists/technologists and be able to present ideas and arguments
- Presents clear, concise, well-organized reports with minimum guidance
- Maintains strict confidentiality
- Uses effective oral and written communication skills
- Deciphers and shares information
4. Customer focus: Anticipates and understands the needs of internal and external customers.
5. Delivery and results: Able to focus on key objectives. Able to make informed decisions, based on risk and consequence analyses. When developing submission work, able to prioritize tasks with the team.
6. Flexibility/ adaptability: Ability to actively manage ongoing change. Able to adopt means of communication and interaction to people from different cultures.
7. Self awareness: Seeks feedback and discusses own strengths and weaknesses and embraces new ways of working and alternative behaviors. Emphasizes the positive aspects in difficult situations. Has positive belief in personal capability. Actively anticipates and responds to the feelings, needs and concerns of others.
8. Strategic thinking: Able to identify current key issues and anticipate key future issues and take them in consideration in the planning and management of projects. Able to challenge the status quo to achieve continuous improvement.
9. Team working: Proficient in people management. Able to guide, direct and mentor staff at multiple levels. Demonstrates and encourages collective responsibility in teams. Able to influence through communication based on logic and reason and to respond constructively to the needs of others. Able to negotiate effectively. Able to command respect at all levels and cultural interfaces.
10. Technical: Knowledge of new drug development process, Knowledge of project management
Function
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