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Senior Associate Regulatory Affairs, Sindan Pharma

Date: Oct 13, 2021

Location: Bucharest, RO, 011171

Company: Teva Pharmaceuticals

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!

The responsibilities for this position include but are not limited at:

 

1.Active participation in the development of assigned projects:
• Provide regulatory advice for developing and producing the required product for the targeted countries within the defined timelines and quality standards. 
• API: assess from a regulatory perspective the regulatory and technical documentation of the potential and selected source(s) (Technical Data Packages, Drug Master Files and Certificates of Suitability). 
• API and excipients: provide regulatory support to the R&D team and/or QC for creating or amending and justifying the development/production and registration specifications in line with current regulatory requirements for the targeted countries;

 

2.Achieve and maintain marketing authorizations in target countries, the main tasks being:
• Collect, evaluate and criticize data for inclusion in marketing authorization dossiers;
• Compile dossiers (Module 3 and corresponding QOS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements while not being overly restrictive. 
• Respond to queries (from regulatory authorities or clients) concerning dossiers
• Keep the dossier master files (Module 3 and corresponding QOS) fully up to date during registration procedures and as a consequence of a variation or of a site transfer.

 

3.Contribute to regulatory life-cycle management by:
• Actively participate in the change control system and variation process 
• Perform the task for regulatory change control evaluation: inform the US/CA/JP/LATAM and other regions, as applicable;
• Contribute to Technical Data Packages and participating actively in transfer teams as required;
• API: assess from a regulatory perspective the regulatory and technical drug substance documentation in case of second API source or update of Drug Master Files/CEP taking into account the quality of the material and of the documents already approved. 
• Provide regulatory support to the Stability unit for designing the stability program for supporting the post-approval change. 
• Prepare the variation and post-approval change packages and other necessary documents as required by the variation process;
• Respond to queries (from regulatory authorities, Teva internal departments/affiliates or clients) concerning changes;
• Evaluate and advise on the regulatory implications of proposed changes.

 

4. Annual Report Notification (USA/Canada):
• Collection and delivery of requested documentation to USRA for Annual Report completion according to the reporting date defined.

 

5. Provide regulatory expertise and support to Teva’s internal departments/affiliates and Medis’ customers on technical and regulatory issues concerning registration or post-approval change documents; 

 

6. Compliance
• Ensure that all documents and records pertaining to the CMC Department are archived properly. Keep departmental database or other tracking system up to date;
 

Ideal profile:

• University degree in Pharmacy or Chemistry
• Previous work experience in pharmaceutical industry in a similar role is a must
• Good communication skills (both written and verbal) and interpersonal skills
• Master communication (written and verbal) in English
• Organized with good time management skills
• Customer-oriented mindset
• Pro-active and result oriented
• Able to adapt and respond to internal (e.g. priorities) and external (e.g. regulatory environment) change
• Must have an eye for detail and a methodical approach to work
• Responsible and able to work under pressure
• Able to work with sensitive and confidential information
• Computer literacy. Must be experienced in the use of spread sheet and word-processing programs


The offer includes but is not limited at:
• Competitive salary and benefits
• Highly professional environment
• International exposure
• Challenging work environment


 

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

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