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15.06.2020, Ref.#: 21177
★★★ Specialist CMC (Temporary position), Actavis, a Teva company
Месторабота Троян; Постоянна работа; Пълно работно време
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We are looking for qualified and motivated candidates to join the Regulatory Affairs team for the role of

Specialist CMC (Temporary position)

based in Troyan

About the Role
The Specialist CMC will be responsible for the preparation of Module 3 and 2.3 (Quality Overall Summary) of generic pharmaceutical products developed by Teva, intended for Marketing Authorization Applications mainly in European markets, by providing regulatory expertise and support during development and post-approval changes.

Main Responsibilities

  • Support R&D on complex issues around supporting data requirements and challenge proposals that are misaligned with Health Authorities’ requirements and escalate key issues to management
  • Collect and evaluate data for inclusion in marketing authorization dossiers (Module 3); review for regulatory compliance the analytical validation, stability or other protocols with regulatory or compliance impact
  • Compile dossiers (Module 3 and corresponding QoS) for presentation to regulatory authorities, taking all necessary measures to ensure that dossiers meet current or emerging new requirements while not being overly restrictive
  • Review for regulatory compliance the Active Substance Master Files and ensure that the documentation of the active substance is appropriate for the submission in targeted countries
  • Support internal file quality evaluation processes and coordinate remedial activities
  • Respond to deficiency CMC questions (from Regulatory Authorities) concerning dossiers submission or changes - manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions in order to respond as rapidly and completely as possible
  • Prepare the variation and post-approval change packages, as well as other necessary documents as required by the regulatory post-approval processes
  • Actively interact and provide information, support and advice to internal departments/affiliates on technical and regulatory issues concerning registration or post-approval change documents

Main Requirements

  • University degree in Pharmacy, Medicine, Chemistry, Biology, or in other area, but pertinent with the field
  • Preferably at least 2 years of experience in the pharmaceutical industry
  • Experience in Drug Regulatory affairs and/or Quality and/or in Analytics, will be an asset
  • Good verbal and written English communication and interpersonal skill
  • Organized with good time management skills
  • Pro-active and results oriented
  • Able to adapt and respond to internal priorities and external regulatory environment change
  • Must have an eye for detail and a methodical approach to work
  • Experience in the use of spreadsheet and word-processing programs and specialized software- Trackwise and Document Management System, will be considered as an advantage

Dynamic and challenging work environment in one of the world leading pharmaceutical company

Opportunity for development in an international company

Competitive remuneration bound with performance

Additional benefits as per the company policy

Organized transport from certain locations

Food allowance

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Since August 2016 Actavis has been part of Teva. In Bulgaria the combined company is working under the Actavis brand and is the largest employer in the pharmaceutical industry. Actavis - a Teva company - manages two manufacturing plants, sales and marketing organization and a number of global corporate functions.

Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

If this sounds like the right opportunity for you, apply directly online through the button ‘Apply’ and send us your CV in English.
All personal data is protected by law and will be treated in confidentiality.

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