Corporate Regulatory Compliance Specialist

Chiesi Farmaceutici S.p.A.; Bois-Colombes; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading pharmaceutical company in France is seeking a Corporate Regulatory Compliance Specialist. Responsibilities include ensuring compliance with pharmaceutical standards, managing regulatory and quality activities, and supporting lifecycle changes. The ideal candidate has a degree in scientific disciplines and 2-3 years of relevant experience. This role offers a dynamic environment with opportunities for professional development and a flexible working approach.

Prestations

Continuous training and development

Flexible working approach

Support in the relocation process

Qualifications

• 2-3 years of experience in manufacturing and/or analysis in pharmaceutical companies.
• Experience in regulatory and/or quality positions.

Responsabilités

• Ensure compliance with pharmaceutical standards and internal procedures.
• Support regulatory compliance of operations.
• Provide global products lifecycle regulatory support.
• Manage global products lifecycle quality compliance activities.
• Assist in lifecycle changes compliance assessment.
• Facilitate communication between manufacturing plants and Global Regulatory Affairs.

Connaissances

Knowledge of applicable national and international legislation

Knowledge of reference pharmacopoeias monographs

Knowledge of GMP and Quality Systems

Knowledge of regulatory framework and registration dossier

Experience in manufacturing and/or analysis in pharmaceutical companies

Experience in regulatory and/or quality positions

Formation

Degree in scientific disciplines (CTF, Chemistry, Biology, Industrial Chemistry, Pharmacy)

Description du poste

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.

Responsabilities

• 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 (CTF, Chemistry, Biology, Industrial Chemistry, Pharmacy)

Soft Skills

• Establish good and proficient interpersonal relationships
• Ability to quickly get used to new, dynamic and multicultural working environments
• Attitude to problem solving and flexibility to find new solutions and alternative routes
• Organizational skills and time management skills
• Goal-oriented approach and respect of deadlines
• Ability to establish good professional collaborations with members of a work group, even under stressfull situations.

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment. We invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.

We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. We offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.