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Regulatory Affairs Associate

Date: Jun 27, 2022

Location: Rho, IT, 0000

Company: Teva Pharmaceuticals

Who we are

 

Teva, world leader with over 40.000 employees, in the field of equivalent medicines, with a differentiated business that also includes specialist medicines, over-the-counter drugs and the production and marketing of APIs (active pharmaceutical ingredients), is present in Italy for over 25 years with a commercial branch and manufacturing sites.
Our mission is simple: improve the wellbeing of our patients.
We care about them and about our colleagues, creating a respectful, diverse and inclusive working environment, committing ourselves to maintaining high standards of quality, compliance and safety, always respecting our values: Teva Code of conduct.


We all work for one company and we work together to achieve a common goal.

Reporting to

 

Regulatory Affairs Senior Manager

Main activities and responsibilities

 

Responsibilities:
•Manages the regulatory aspects and related tasks of the assigned commercial APIs.
•Performs activities, while keeping the knowledge up to date, based on Teva policy and guidelines of the international Regulatory Authorities.
•Proactively collaborates with the Regulatory Administrative team members, which release and submit the finalized API’s dossier or documentation.

 

Main activities:
•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.
•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.
•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.
•Support customers as a RA assignee of Service Requests, giving relevant information with professional answers.
•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.

Requirement

 

Education:
•Minimum: University Scientific Degree.
•Preferred: Specialty in Chemistry, Industrial Chemistry and Pharmaceutical Technologies.

Experience:  
•Minimum: 5 years work experience in Regulatory in a fine chemical industry. Working experience in Quality and R&D will be also considered as a plus. 
•English Language: good professional level, both in writing and speaking.

What we offer?

 

We try to take care of our employees, offering them small and large benefits. By way of example:
•Recognition Program
•Health insurance
•Canteen
•Coffee Key
•Smart working possibility
•Welfare platform

 

Type of contract: permanent

Department

 

Regulatory Affairs

Location and working program

 

Rho (MI) site, from Monday to Friday.

Teva's commitment to equal opportunities

 

Teva is committed to equal opportunities in the world of work. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity or gender expression, or any other legally recognized status that is entitled to protection under applicable laws.