Teva Pharmaceuticals Regulatory Affairs Associate III - 1436 in Rho, Italy

Regulatory Affairs Associate III - 1436

Date: Dec 7, 2018

Location: Rho, IT, 20017

Company: Teva Pharmaceutical Industries Ltd.

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

RESPONSIBILITIES:

  1. Manages the regulatory aspects and related tasks of the assigned commercial APIs

  2. Performs activities, while keeping the knowledge up to date, based on Teva policy and guidelines of the international Regulatory Authorities.

  3. Proactively collaborates with the Regulatory Administrative team members, which release and submit the finalized API’s dossier or documentation.

MAIN ACTIVITIES:

  1. Maintain up to date the various dossiers filed to the relevant regulatory Authorities, by submission of DMF amendments or total updates in a suitable format, while managing the upgrade of the technical content of the file, according to the available information.

  2. In order to improve the business in the new markets, develop a dossier in line with Teva policy and in compliance with the local Authority requirements.

  3. Reply to additional information requests from Health Authorities (clarification or lack of information on the technical content of the file), while proactively interfacing with the relevant departments, in order to collect and elaborate appropriate answers to the questions raised.

  4. Support customers as a RA assignee of Service Requests, giving relevant information with professional answers.

  5. Participate, if needed, to internal meetings (with production, QA, QC and R&D) or conferences with customers or marketing staff, in order to help solving technical or commercial issues.

Qualifications

Education :

Minimum: University Scientific Degree

Preferred: Specialty in Chemistry, Industrial Chemistry or Chemistry and Pharmaceutical Technologies

Experience :

Minimum: 5 years work experience in R&D or Regulatory in a fine chemical industry.

Skills :

English Language: good professional level, both in writing and speaking

Excellence in Execution

Problem solving

Collaboration and teamworking

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

EOE including disability/veteran