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Regulatory Affairs Associate

4 mesi fa

Rho, Italia Teva Pharmaceuticals A tempo pieno

Who we are

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.

Main responsibilities and activities

In the Regulatory Department we are looking for a brilliant profile reporting to the Regulatory Affairs Senior Manager with the following responsibilities and activities:

Main 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.

Requirements

Education:

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

Experience:

Minimum: 3 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 and Italian 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:

Canteen Working flexibility for Caregivers and parents Coffee Key Recognition Program Wellbeing Digital Platform Welfare Platform Health agreement with medical centers of excellence  Flexible working environment (2 days home office per week) Highly inclusive and multicultural working environment Continuous learning and development programs (with full access to Linkedin Learning)

Type of contract: long term contract

Location and working program

Rho (MI), 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, gender expression, protected categories or any other legally recognized status that is entitled to protection under applicable laws.