9 days old

Senior Regulatory Affairs Associate

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 Senior Regulatory Affairs Associate is a tactical role within Specialty Products RA and is generally responsible for submitting routine regulatory submissions as well as working with their Supervisor on obtaining approval of regulatory submissions through interactive communication with the FDA for investigational and/or marketed drug products.  The candidate for this positions is expected to have had previous experience supporting regulatory activities. Incumbent may need to travel locally to support business needs (e.g., meetings with FDA, reg.  conferences, etc.).

 

Essential Duties & Responsibilities:
 

  • Review and prepare routine (e.g., investigator submissions, correspondence to FDA, etc.) regulatory submissions as well as support senior-level staff in the preparation, QC, and submissions of major submissions (initial INDs, NDAs, sNDAs) for investigational and/or marketed drug products.
  • Work with Supervisor to develop regulatory strategy on preclinical, clinical and/or CMC issues (Senior Regulatory Associate may be afforded independence to develop initial draft for review by supervisor).
  • Regulatory Intelligence (research regulations, guidance, precedence) responsibilities as assigned by Supervisor.
  • Coordinate and support the team in planning and preparation for FDA meetings or teleconference.
  • Develop and submit routine submissions to FDA and support senior-level staff with major submissions.
  • Provide strategic information to stakeholders (supervisor, senior-level RA staff) from regulatory intelligence gathering exercises.
Qualifications

 

Minimum Qualifications:

  • Bachelor's Degree in scientific field of study such Biology or Chemistry
  • 2+ years of pharmaceutical industry experience in new drug related product strategy and submissions, including working knowledge of FDA regulations and guidance for new drugs


Preferred Qualifications:

  • RAC Certification
  • Graduate training in science, Regulatory Affairs and/or Drug Development
  • Evolving understanding of regulations/guidelines governing development of pharmaceuticals
  • Basic understanding of 21 CFR and FDA guidances, GCPs, GMPs, GLPs
  • Detail Oriented, capacity to integrate the broad picture as well as detailed analysis, thinks through consequences of different courses of action
  • With limited oversight, able to work on researching regulatory information and making assessment of relevance of regulatory information on submissions
  • Strong foundation of communication skills and evolving capacity to learn negotiation skills
  • Ability to effectively communicate with scientists/technologists and be able to present clear ideas and arguments
  • Presents clear, concise, well-organized reports with minimum guidance, and maintains strict confidentiality
  • Customer Focus, anticipates and understands the needs of internal and external customers
  • Ability to focus on key objectives, and to make informed decisions, based on risk and consequence analyses
  • Able to prioritize tasks with the team
  • Ability to actively manage ongoing change and to adopt means of communication and interaction to people from different cultures
  • Proficient in project management
  • Knowledge of Regulatory submissions and registrations, proficiency with regulatory IT systems, knowledge of regulatory requirements, process, procedures, & pathways
  • Knowledge of new drug development process, as well as post-marketing surveillance/vigilance

 

 

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

Categories

Posted: 2020-05-18 Expires: 2020-06-21

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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Senior Regulatory Affairs Associate

Teva Pharmaceuticals
West Chester, PA 19380

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