Finished Products Regulatory Affairs Specialist

6 giorni fa

Bardi, Italia Chromavis A tempo pieno

Funzione:_ REGULATORY
- Sede:_ Offanengo, Italy
- Contratto:_ Full Time
To guarantee the finished products are compliant versus customer and internal expectations, following the regulation applicable on the different countries concerned and watch to its maintenance. To ensure the regulatory compliance about the finished products.
To perform regulatory checks following Customers Ban list and international regulations regarding customers and internal briefs and requests. To prepare pre-safety assessment and submit them to the safety assessor.
To select external laboratories following liability, prices and delays in order to quote and organize safety and efficacy tests respecting product categories and claims.
To plan, to organize, to gather and to spread safety and efficacy testing
results while helping interpretation of them.
To check finished products labelling regarding the regulation in force
To evaluate PAO and Shelf life of the products.
To gather all documents for safety assessment requests and ask for safety assessment.
To register CPNP notifications where relevant.
To gather all data and documents needed in the Product Information File, OTC reports and specifications for sending to the customers and archive them.
To update Safety assessments, PIF/OTC reports and Specifications for existing products following the regulations in force in the case of change controls.
To follow new developments, answering to customers' requests or local authorities
and gathering complementary data if necessary.
To be regulatory support for customer's registrations and
legalizations.
To ensure Regulatory, scientific and technologic watch for Europe and International countries.
To manage regulatory watch on going topics when necessary.
To participate in building and maintenance of regulatory database.
To ensure that the data entered is accurate and justified to improve data centralization.
**Communication - Comunicazione**
70% INTERNAL - R&D, Sales, PM, Marketing, Procurement
30% EXTERNAL - Customers, External Labs., Suppliers, Ministery of Health
**Education required for the role - Titolo di studio**
Bachelor Degree or qualified experience in the position
**Foreign Language knowledge - Conoscenza lingue straniere**
Good knowledge of English
**IT Knowledge - Conoscenza Information Technology**
Good level of knowledge of SOP & other IT tools (COPTIS, Pack Office)
**Work Experience - Esperienza Lavorativa**
3 years of experience in the same role
**Knowledge, Skills and Abilities - Altre conoscenze, competenze e abilità**
Regulatory Knowledge
Toxicological Knowledge
Project data management ( RM, formula, process)
Rigor/Attention to detail, Adaptability. Collaboration, Organization and Communication skills
Good knowledge of GMP roles
Teamworking
Company equipement management
Respect company policy, safety & quality rules
Tact and Diplomacy
Employee

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