Global CMC Regulatory Affairs Senior Specialist

2 settimane fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Who We Are Looking For Purpose

Responsible for:

• Developing and implementing comprehensive and innovative Regulatory-CMC strategies globally, covering the entire product life-cycle (pre-clinical, clinical, post-market and change management) for Chiesi's global offerings, including chemically synthesized products, biologics, and medical devices (including combination products).

• Serving as the Regulatory Affairs representative or leader for CMC matters within project teams to ensure effective planning, communication, and support for decision-making processes.

• Drafting internal Regulatory CMC work instructions and standard operating procedures, and contributing to regulatory documentation as needed.

• Conducting thorough analyses and sharing of external CMC regulatory intelligence, actively participating in discussions related to regulatory-CMC topics.

• Collaborating as a proactive member of the GRA-CMC Life Cycle Management Unit to foster teamwork, communication, and continuous improvement in efficiency and excellence, ensuring alignment in execution and sharing of best practices across Chiesi's Regulatory-CMC units.

• Establishing and nurturing relationships within and outside the Regulatory Affairs group, particularly with Global Technical Development, Global Manufacturing Division, Global Rare Disease Unit, and extended teams.

Main Responsibilities


• Act as the Regulatory-CMC representative or leader in regulatory and project meetings in accordance with the Omnis model.

• Provide independent input and expertise for the formulation and execution of Regulatory-CMC standards and procedures (including drafting GRA-CMC work instructions, standard operating procedures, and tools).

• Accountable for the development of Regulatory-CMC strategies and the preparation, writing, and management of quality regulatory documents throughout the entire life-cycle of drug products.

• Independently assess regulatory implications of Change Control, preparing CMC-related development and life cycle change management documentation.

• Engage with both internal and external stakeholders independently.

• Contribute to the collection, analysis, commentary, and dissemination of external regulatory-CMC intelligence and information.

• Provide regulatory CMC review and input to processes and documents from other departments (e.g., standard operating procedures, specification committees, device documentation).

• Offer specialized contributions in identified quality-specific areas as a Subject Matter Expert.

Experience Required

A minimum of 5 to 8 years of experience in global drug Regulatory CMC and CMC Development.
Comprehensive experience in drug development, manufacturing, and supply chain processes within the pharmaceutical sector.
Proven ability to manage complex global CMC challenges through ongoing change and enhancement.

Education

At least a Bachelor's Degree in Chemistry, Pharmaceutical Technology, Pharmacy, Biology, or a related field.

Languages

Proficient in English.

Technical Skills

Extensive understanding of the complete drug development process. In-depth knowledge of global drug regulations, regulatory procedures, and drug development guidelines. Proficient in navigating various quality regulatory requirements.

Soft Skills
  • Adaptability and flexibility
  • Emotional and social intelligence
  • Negotiation skills
  • Team collaboration
  • Strategic thinking

What We Offer

Join a dynamic, rapidly growing, and supportive environment. At Chiesi, we believe that our people are our greatest asset, which is why we invest in ongoing training, learning, and development. We are committed to promoting and addressing development needs while prioritizing the quality of our work environment and collective well-being.
We want our employees to feel fulfilled at work every day, recognizing the importance of achieving a healthy work-life balance to perform at their best. Therefore, we provide flexible working arrangements, remote work options, assistance with relocation, tax support for international colleagues, and a variety of employee care services.

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