Corporate Regulatory Affairs - Pharmaceutical Milano

Corporate Regulatory Affairs - Pharmaceutical
Milano
Lombardia, Milano

Regulatory Affairs Specialist/Sr.

Specialist

The Regulatory Affairs Specialist/Sr.

Specialist will be part of the Corporate Regulatory Affairs team and will be responsible for the management of regulatory activities such as obtaining and maintaining marketing authorizations through the implementation of the procedures in use in the European Union (CP, MRP / DCP, CP) as well as in various non-EU geographical areas (Africa, Asia Pacific, CENAM, CSI, LATAM, MENA).

My client is an International Pharmaceutical Group, dedicated to the research, development, manufacturing and marketing of innovative pharmaceuticals, including a specialised business dedicated to treatments for rare diseases.

It is a company where I've had extremely good feedback from those who I have placed there before and things are only getting better.

new Marketing Authorization Applications

line-extension,

renewal of marketing authorizations

variations of type IA, IB, II (grouping and worksharing procedure) or equivalent in accordance with national legislation

Notification of start/end of marketing

marketing authorization transfer

review and approval of printed material (artworks and mock-ups)

Based on the products assigned, the Regulatory Affairs Specialist/Sr.

Specialist will also:

coordinate the preparation of discussions and negotiation with various Regulatory Agencies;

participate in the management of core dossiers of corporate products, including gap-analysis activities, to support the registration in different territories worldwide, collaborating with the relevant departments;

coordinate with the group's affiliates, licensees and consultancy companies and will maintain relations with the Regulatory Authorities;

monitor the legislation in force and define a plan and costs of the required activities

Skills and experiences required

5-7 years experience within the regulatory affairs area of multinational pharmaceutical companies (preferably "parent companies") or regulatory consultancy companies operating internationally

Scientific degree

High level knowledge of English

Experience in the use of IT systems for the management of data and regulatory documents (RIMS, DMS, eCTD platform), eCTD platforms and regulatory document management

HQ is in Milan.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe.

We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry.

We have a strong presence within Italy as well as Germany, Switzerland, France, The Nordics and Benelux.

Please visit our website for a full list of the niche markets we cover.