12 days old

Quality Management/Regulatory Affairs Associate

Cambridge, MA 02139

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!

 

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k),Employee Stock Purchase Plan and Tuition Assistance. or more information on Teva, check us out at www.tevapharm.com or www.tevausa.com
 

 

R&D:
Tevas Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.
 

 

In your new position you will report to into our Sr QMS/RA Manager, GMP Product Management.

 

 

Responsibilities:


 Assist in documentation reviews and approvals needed for compliance with Tevas quality management system.
 Assist in creating and maintaining medical device regulatory submissions (EU technical documentation, 510(k), PMA)
 Assist in keeping Tevas SOPs/strategic objectives/work instructions up-to-date as per applicable regulations/standards and internal company guidance.
 Assist in EU post-market activities such as collection of surveillance data, vigilance and reporting
 Review product labelling to ensure regulatory compliance in the US and EU markets
 Coordinate with cross-functional teams, consultants and business vendors to ensure overall product development as per applicable quality and regulatory requirements.
 

Categories

Posted: 2021-02-16 Expires: 2021-03-18

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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Quality Management/Regulatory Affairs Associate

Teva Pharmaceuticals
Cambridge, MA 02139

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