11 days old

Director, Regulatory Affairs

West Chester, PA 19380
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description


The Director, Neurology Brand Lead position, as part of the Global Specialty Regulatory Affairs Department is a strategic role that will be responsible for developing, coordinating, and implementing regulatory strategies for new products and marketed products.  This role is responsible for the management and execution of our flagship Neurology product as well as earlier clinical development programs.  Teva is focused on being a global specialty company and this role will provide oversight of the global registration strategies to obtain marketing approval in our focus countries as well as expanding into new indications with our approved products.

This is a highly visible position with an expectation to provide innovative strategies before senior management. This position also has 2 RA strategists reporting into it, offering an opportunity to manage and mentor.


The position requires regulatory experience with either IND or NDA/BLA content and submission experience.


  • Develop/coordinate/implement regulatory strategy through a global regulatory team approach for branded products.Takes responsibility for ensuring timely development for regulatory strategy and operating plans. Regularly reports to management on progress against objectives and plans. Plans and directs projects and   provides technical background, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team
  • Point-lead for interfacing with Health Authority review teams and is a leader that facilitates approval of regulatory submissions and coordinates appropriate responses to Health Authorities with appropriate personnel and departments to resolve outstanding regulatory issues
  • Arranges for, coordinates and leads the team in planning, preparation, and execution (lead facilitator) for meetings or teleconferences with Health Authorities (e.g., FDA, EMA).
  • Provides training and mentorship to regulatory staff. Independently develops Regulatory Intelligence to support above activities.  Leads due diligence for assigned GBP products.


Domestic and international travel up to 10% pending project assignments (FDA or project team meetings)


Minimum Requirements:

  • Bachelor's degree in scientific field of study such as Biology or Chemistry
  • 7+ years of pharmaceutical industry experience in new drug regulated product strategy and submssions; including working knowledge of FDA, EMA and Health Canada laws/regulations/guidance applicable to registration and approval of drugs or biologics


Preferred Requirements:

  • Master's degree or PhD
  • 4+ 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.
  • Specialized or Technical Knowledge Licenses, Certifications needed: Working knowledge of relevant drug and biologic laws regulations and guidances / guidelines
  • Experience with IND, NDA, and/or BLA filings
  • Excellent communication and organizational skills
  •  Experience with eCTD


Job-specific Competencies:

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

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

Interpersonal: Proficient in project management. 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.
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

Technical: Knowledge of new drug development process, knowledge of project management

Demonstrates proficiency with computer and familiarity with electronic document management

Flexibility/ adaptability: Ability to actively manage ongoing change. Able to adopt means of communication and interaction to people from different cultures.

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.

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.


Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To

Vice President, RA Head of Neurology, Pain and Migraine

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.


Posted: 2020-05-19 Expires: 2020-06-20

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Director, Regulatory Affairs

Teva Pharmaceuticals
West Chester, PA 19380

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