1+ months

Director Regulatory Affairs, Biologics

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, Regulatory Affairs, Biologics as part of the Global Specialty Regulatory Affairs Department is a strategic role and that will be responsible for developing, coordination, and implementing regulatory strategies for new biologic products as well as marketed products. This position will support the development and lifecycle management of therapies for conditions in Respiratory, Oncology, and Womens Health therapeutic areas.
The position requires regulatory experience with either IND or NDA/BLA content and submission experience.
 
Domestic and international travel up to 10% pending project assignments (FDA or project team meetings)

 

1. 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.
 
2. 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.
 
3. 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).
 
4. Provides training and mentorship to regulatory staff. Independently develops Regulatory Intelligence to support above activities.  Leads due diligence for assigned global branded products.

Qualifications

Position Requirements
 
Education Required: Bachelors Degree in scientific field or equivalent combination of education and related work experience
Education Preferred:  PharmD, Ph.D., or Masters degree
Experience Required: Minimum of 5+ years 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 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
Functional Knowledge: Experience with IND, NDA, and/or BLA filings
Excellent communication and organizational skills
Company/Industry Related Knowledge: Experience with eCTD

Job-specific Competencies:
 
1. Autonomy: Able to work independently on researching regulatory information and making assessment of relevance of regulatory information on submissions.
2. 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
3. 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.
4. 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
5. Technical: Knowledge of new drug development process, knowledge of project management
Demonstrates proficiency with computer and familiarity with electronic document management
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.

 

Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To
In process of validation
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Categories

Posted: 2019-12-27 Expires: 2020-03-14

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, Biologics

Teva Pharmaceuticals
West Chester, PA 19380

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