Company: Mosaic Regulatory Solutions
Closing Date: 16 Dec 16
Salary (£): Negotiable
To apply for the for this regulatory affairs role please call Julie Cooper on 07951 082482 or send your CV to: email@example.com
Head of Regulatory Affairs Italy
Role - Head of Regulatory Affairs
Supervise and lead all Country Regulatory Affairs activities in Italy.
Ensure full compliance with all relevant Italian laws and regulations regarding the local product portfolio. Make sure all relevant licences are available and maintained.
Support the New Product Development activities of the Corporate multifunctional category team with country specific regulatory input.
Manage due diligence for country specific products & support the Corporate team for their due diligence in Italy.
Supervise the Country Quality Management Systems in place (typically for GDP for Medicines).
Ensure proper internal (Corporate Safety Surveillance and Quality Assurance) and external (Authorities) safety/quality case reporting.
Create access to Regulatory networks with Authorities and Key Opinion Leaders.
Maintain a high level of Regulatory intelligence on existing and developing regulations in Italy.
Manage country audits and inspections.
Maintain the Regulatory Affairs database – product data, regulatory landscape info, registration/notification data, ...
Master degree in sciences (e.g. pharmacy, biology, chemistry, nutritional engineer, …) or equivalent through experience.
At least 7 years of relevant experience in regulatory affairs for OTC medicines, preferably a big part in Italy.
Good knowledge of Italian regulations related to medicines.
Genuine leader, leading by example.
Good presentation skills to high-level audiences.
Clear communicator and solution orientated.
Strong project management skills & team worker in a multicultural environment.
Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills.
Sound overall knowledge of the pharmaceutical/consumer goods market in Italy and good understanding of how Regulatory Affairs can contribute to the development of this business.
You speak and write fluently English.
Evidence of hierarchical supervision and mentoring of people.
Additional expertise in Substance Based Medical Devices, Cosmetics, Food Supplements and Biocides is a plus.
Our offer :
? A key Regulatory Affairs position for an ambitious and energetic professional.
? An appealing career opportunity in a dynamic, strong growing multinational environment.
? Apart from a competitive remuneration pack we offer you excellent personal development and growth opportunities.
Keywords: Head of Regulatory Affairs, Associate Director Regulatory Affairs, Regulatory Affairs Senior Manager, Senior Regulatory Affairs Manager, RA Manager, Experienced RA Manager, Director Regulatory Affairs, Italy , Head of Regulatory Affairs , OTC
Mosaic Regulatory Solutions Ltd
|Tel:||0208 305 9733|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.