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As Manager, CMC Regulatory Affairs you will be responsible for managing the day-to-day chemistry, manufacturing, controls (CMC) regulatory activities for all assigned marketed products, as well as those products that are currently in development. You will be responsible for compiling, organizing, and assessing documents for regulatory submissions to health authorities (e.g., FDA, Health Canada) as well as working with global regulatory colleagues in preparing dossiers for products for global registration. You will be responsible for maintaining and updating CMC sections of submissions for assigned products.
As Manager CMC Regulatory Affairs you will also be responsible for identifying and evaluating CMC issues associated with development products, including product and process development, analytical methods, formulation development, manufacturing, and labeling. You will interface with development and manufacturing groups, as well as with internal regulatory departments, provide for support cross functional product teams for CMC specific projects and may assist in the planning and conduct of meetings with FDA.
Other duties:
Required Qualifications:
Preferred qualifications:
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, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
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.
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Nearest Major Market: Philadelphia
Full Time
Pharmaceutical
$131k-174k (estimate)
02/28/2024
05/09/2024
tevapharm.com
FAIRFIELD, NJ
15,000 - 50,000
1901
EREZ VIGODMAN
$200M - $500M
Pharmaceutical
Teva Pharmaceuticals has been developing and producing medicines to help improve peoples lives for more than a century. We are committed to being a global leader in generic and specialty medicines with a portfolio of 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day. They are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biop...harmaceutical products. Learn more at www.tevapharm.com. Please note that adverse effects for any of our products should be reported to: Safety.AE@teva.co.il Product-specific questions should be directed to Teva or Teva Group subsidiaries in your country. Contact details and Teva's Pharmacovigilance Privacy Policy may be found here: http://www.tevapharm.com/contact_us/
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