Corporate Regulatory Compliance Specialist

Corporate Regulatory Compliance Specialist
Department:
Corporate Quality Operations
Job Type: Direct Employee
Business Area:
Industrial Operations & HSE
Contract Type:
Temporary

Location:

Parma, IT

About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas:
Discover more here
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Global Manufacturing Division
Chiesi Group has three production plants:

Parma (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.
In 2024, a new Biotech Centre of Excellence has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.
Blois-La Chaussée Saint Victor plant (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.
Santana de Parnaiba (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).
In 2025, a new investment in Nerviano (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.

Responsibilities

Compliance to pharmaceutical standards and to internal procedures,
Regulatory compliance of operations (production and analytical documents and processes) to Chiesi Global MAs,
Global Products lifecycle regulatory support (i.e. CMC documentation review, deficiency letter responses, documentation for first registration),
Global Products lifecycle quality compliance activities (i.e. item codes attributes on SAP system, materials specifications on LIMS system),
Support to lifecycle changes compliance assessment and to changes implementation phase,
Bridging activities between manufacturing plants (internal and external) and Global Regulatory Affairs

Technical Skills

Knowledge of applicable national and international legislation (EMA, FDA, ICH guidelines, etc.)
Knowledge of reference pharmacopoeias monographs (EP, USP mainly).
Knowledge of GMP and Quality Systems.
Knowledge of regulatory framework and registration dossier of MAH.

Required experience

Experience in manufacturing and/or analysis in pharmaceutical companies at least 2-3 years
Experience in regulatory and/or quality positions.

Education
Degree in scientific disciplines…