Teva Regulatory Affairs Associate II 

United States, Pennsylvania, East Bradford Township 

731282945

Travel Requirements:
Domestic and international travel rarely required.

• With support from the supervisor, is responsible for maintain the regulatory compliance of marketed products, including annual reporting and safety reporting requirements
• Participates in cross functional teams including Global Regulatory Team, Clinical Development Team and Project teams
• With support from the supervisor, coordinate in planning, preparation, and execution of Health Authority meetings. Also, interact with the FDA regarding pre-clinical and clinical development issues and provide support to our ex-US Regulatory counterparts regarding preclinical and clinical support, as needed
• Oversee and ensure the preparation of INDs, NDAs, sNDAs, BLAs, and MAAs including liaising with U.S. and ex-U.S. regulatory personnel as required. Conduct gap analyses in a timely manner. Oversee the maintenance of INDs and NDAs, and ex-U.S. filings as required.
• Represent the RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.
• Follows Teva Safety, Health, and Environmental policies and procedures
  

Education Required:

• Bachelor’s Degree in scientific field or equivalent combination of education and related work experience.

Preferred Education /Competency:

• PharmD, PhD, or Master’s degree

Experience Preferred:

• Experience in Pharmaceutical, Research or Pharmacy Field

Company/Industry Related Knowledge:

• Knowledge of FDA
  

Competencies that are necessary for the incumbent to do this position and that distinguish it from others similar to it.

⦁ Able to work independently on researching regulatory information and making assessment of relevance of regulatory information on submissions.

⦁ 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 clear ideas and arguments.
⦁ Presents clear, concise, well-organized reports with minimum guidance.

Planning and Organization

⦁ 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.
⦁ Ability to prioritize and manage multiple priorities effectively Attention to detail.

⦁ Knowledge of new drug development process
⦁ Knowledge of project management
⦁ Demonstrates proficiency with computer and familiarity with electronic document management.

⦁ Ability to actively manage ongoing change.
⦁ Able to adopt means of communication and interaction to people from different cultures.

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.

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