Regulatory Affairs Specialist

Regulatory Affairs Specialist – Piacenza Office

Coree S.R.L., the Italian branch of a multinational group headquartered in South Korea and China, is looking for a Regulatory Affairs Specialist to join its Piacenza office.

The company is engaged in the development of innovative concepts in the fields of food, food supplements, medical devices, and pharmaceuticals, with a growing focus on probiotic-based medicinal products.

Key Responsibilities:

• Regulatory feasibility assessment for the registration of new products, with a focus on pharmaceuticals and probiotics;
• Definition of the most suitable regulatory strategy for product development;
• Preparation of dossiers for submission to regulatory authorities;
• Ensuring legal compliance of company products (raw materials, labeling, formulations);
• Issuance of technical specifications, declarations, and supporting documentation;
• Management of documentation required for registration in foreign markets;
• Updating and management of international registration portals;

· Keep updated about international food, food supplements, medical devices and drug legislation;

• Monitoring and interpreting national and international legislation on pharmaceuticals, food supplements, and medical devices;
• Supporting regulatory compliance of documents and procedures related to clinical trials sponsored by the company;
• Acting as a liaison with the international corporate teams (China and South Korea) for the exchange of technical and regulatory documentation.

Ideal Candidate Profile:

• Degree in Life Sciences (e.g., Pharmaceutical Chemistry and Technology, Pharmacy, Biology, Chemistry, Biotechnology, or similar);
• Proven experience in pharmaceutical regulatory affairs (nice to have: experience with probiotics and/or Master's degree in regulatory affairs)
• Familiarity with regulatory requirements for food supplements and medical devices (flexibility and willingness to work on these topics is appreciated);
• Strong writing and editing skills with excellent attention to detail;
• Excellent organizational and time management abilities;
• Fluent written and spoken English is essential due to frequent interaction with foreign headquarters.

Why Join Us:

• Be part of groundbreaking probiotic development projects in a fast-evolving regulatory environment.
• Work alongside global teams and play a key role in shaping public health outcomes in Italy and across the EU.

Job Offer:

• Direct employment with the company under the Italian Terziario National Collective Labor Agreement (CCNL Terziario);
• Salary and level will be based on the candidate's experience and qualifications;
• Workplace: Piacenza (on-site, full-time).