Regulatory Affairs Manager - Milan, Italy

Key People

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Job ID :

11822


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,--Milan,Milan,


Key Skills :

regulatory affairs, manager, regulatory manager, senior regulatory officer, milan, italy


Salary :

€45000 - €55000 per annum


Date Posted :

12 Jun, 2018



Company Name :

Key People


Location1 :

Milan




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

An excellent opportunity has arisen for a Regulatory Project Manager / Regulatory Manager to join a growing biopharma based in Milan, Italy. Within this role, you will be the main point of contact for all local submissions to AIFA. An experienced candidate is required with the ability to project manage and lead submissions.

As Part of the Corporate Regulatory Affairs team you will support all products in all markets across the business. In addition, you will support the local affiliate management team.

Responsibilities:
- Preparation of documentation and submissions to Health authorities, including AIFA and Ministry of Health in compliance with current legislation to ensure efficient registration and maintenance of the registrations in accordance with business strategies.
-Proactive management AIFA open issue monitor , collect and interpret and apply all relevant legislation, regulatory trends and regulatory guidelines in Italy and keep the Italian business up to date on national regulatory trends, risks and opportunities , provide advice to the business as necessary and assist plan of action.. Interface with AIFA and industrial trade association.
- Maintaining and processing of local regulatory database
- Responsibility to gather all the necessary materials to submit products to regulatory authorities globally
- Professional and timely response to authorities' questions
- Strict cooperation and synergy with Company SOP's
- Reporting to the Corporate Regulatory Affairs Head, you'll be part of a multicultural cross-functional team where diversity is very high both in terms of gender and in terms of nationality, where performance and achievement are the common ground to build growth.

Requirements:

- University degree in life scientific (preferably pharmacy or pharmaceutical chemistry)
- At least 4-5 years of experience in healthcare companies in regulatory role dealing with medicines
- Familiarity with AIFA procedure and timelines Familiarity with module 1-5 , able to t prepare the documentation for the layout of the variations, and the GAP analysis.
- Good knowledge of Guidelines ICH/EU, Italian and EU drug legislation
- Italian native and mother-toungue
- Fluent English
- Good written and verbal communication skills with the ability to effectively and precisely present data
- Attention to details with proven ability to establish priorities & achieve results
- Multitasking attitude and problem-solving approach
- High quality and ethical standards

For further details about this role, or other regulatory roles, please contact Tim Barratt on +44(0)1727 817626 or email a copy of your CV to tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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