Ra, Compliance - Pisa, Italia - Octapharma

Descrizione

Job ID:
Location: Pisa, IT- Job Level: Entry Level- Job Category: Regulatory Affairs- Employment Type: Permanent position- Career Level:

Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins.

Working at Octapharma means to have an opportunity to contribute to our common goal - developing lifesaving therapies to improve patients' lives.

We are seeking:

We are looking for a Regulatory Affairs, Compliance & Logistics employee to expand staff in our Italian subsidiary.


Your main responsibilities and opportunities:

• Ensure, in agreement with Managing Director, to obtain new products registrations
• Upgrade/renewal of existing licenses
• Guarantee the implementation of the established programs in compliance with deadlines fixed by Italian regulatory provisions of health matters
• Collaborate with Corporate RA function (IDRA) to the drafting of the parts of registration dossiers requiring local contribution/adaptation
• Update Corporate RA function (IDRA) about local regulatory requirements
• Ensure followup of local registration progress/approvals
• Plan and control, in agreement with Managing Director, drug preregistration and registration activities
• Manage, monitor, issue and update standard operation procedures (SOP)
• Keep archive of personnel training certifications
• Request product allocation to Corporate Supply Chain through the SAP APO system or Sales Order Management tool updating the endofthe month stock data
• Implement guidelines and corporate activities of Good Distribution Practice Regulations interfacing with local Depositary

Your profile:

• Degree in scientific disciplines
• Specialization in Regulatory Affairs and/or Quality Systems Management
• Experience in the role will be evaluated
• Excellent knowledge of English Language
• Organizational ability and flexibility
• Proactive attitude and teamwork capability

Our offer:

• Permanent position
• Report to President & Managing Director
• Friendly and comfortable work environment
• Italian office placed in Pisa, involved both in Italy and Africa milieux

Working at Octapharma:

Whether your interests lie in the field of research and development, production, marketing, sales, finance or engineering, there are many career opportunities at Octapharma

We are the world's largest family-owned plasma company and entirely European.

In the spirit of our founder Wolfgang Marguerre, we do not pursue short-term profit goals, but have future generations in mind.

Our vision:
we are passionate about developing new healthcare solutions that improve lives. We own 6 modern production facilities in Austria, France, Germany, Sweden and Mexico. The Marguerre family continues to play an essential role in the company's day-to-day operations.

Octapharma wants to offer its employees a working environment that challenges them as much as it enriches them. Since its foundation in 1983, the company has grown steadily and today we employ almost 10,000 people.


About Octapharma:

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US.