Johnson & Johnson Careers

Regulatory Affairs Specialist - Permanent Contract

Pomezia (Santa Palomba), Lazio
Regulatory Affairs

Descrizione offerta di lavoro

Requisition ID: 1805657912W

Johnson & Johnson is one of the world's largest groups operating in the Healthcare sector. The Group focuses on innovation as a main driver of growth and invests a significant percentage of its revenue in research and development. J&J is present throughout the world with more than 250 operating companies in 60 countries. The business is organized in three segments, represented in Italy as follows:

FMCG - Johnson & Johnson SpA
The headquarters of the Sales & Marketing Company and factory are both located in Santa Palomba (Pomezia - Rome).

Medical Devices - Johnson & Johnson Medical SpA
The headquarters of the Sales & Marketing Company is located in Practice Sea (Pomezia - Rome), another is based in Milan. There are no production facilities in Italy.

Pharmaceutical - Janssen-Cilag SpA
The headquarters of the Sales & Marketing Company is located in Cologno Monzese (MILAN), while in Borgo San Michele (LATINA) is the only manufacturing plant in Italy.

For Johnson & Johnson SpA -FMCG- we are looking for a new Regulatory Affairs Senior Specialist. The major role responsibilities will include:

Management of all aspects of Regulatory Affairs for the assigned products (OTC, Food Supplements, Cosmetics and Medical Devices).

To obtain and evaluate data for the preparation of medicinal product license applications:

  - Preparation and submission of Marketing Authorization application and other applications/notifications
  - Provide input to European/Global Registration Strategies on behalf of the local
  - To liaise with professional staff at regulatory agencies to facilitate the expedient review and approval of regulatory submissions

To support product maintenance:

  - Preparation and submission of renewal applications and variations to the Italian Health Authorities

To advise on regulatory aspects for new product development projects in Italian market and, where appropriate, work with European group to define regulatory strategy to gain marketing authorizations

Successful candidates will need:

• A previous experiences in regulatory field
• Fluent in English
• Thorough understanding of the current regulations
• Ability to manage workload and identify priority tasks to meet tight deadlines
• Ability to build good relationship
• Scientific degree (Pharmacy, Chemistry, …)

Previous experience in other consumer companies will be considered as plus.

Sede principale
Italia-Lazio-Pomezia (Santa Palomba)
Johnson & Johnson S.p.A. (7170)
Regulatory Affairs
Requisition ID