Biotechnology à Italie

Senior CMC Regulatory Affairs Specialist (M / F)

We are looking for an experienced Senior CMC Regulatory Affairs Specialist to join our Regulatory Affairs team, whose main mission is to ensure that all products meet the necessary legal and regulatory requirements, facilitating their approval and market entry.

As an experienced Senior CMC Regulatory Affairs Specialist, you will provide strategic and operational global CMC regulatory direction and documentation for our injectable products, with a special emphasis on early development activities.

Missions

• Develop and lead a global CMC regulatory strategy to ensure compliance for injectable products.
• Implement global CMC submission activities, including planning, writing, reviewing, and coordinating of regulatory documents (IMPD, IND) for submissions.
• Proactively communicate CMC regulatory strategies, risks, and key issues to project teams and stakeholders.
• Represent the department in cross-functional project teams.
• Lead Health Authority interactions and negotiations.

Profile

Qualifications

• Advanced degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology).
• Minimum of 7 years of regulatory CMC experience in the pharmaceutical industry, with a focus on injectable products.
• Demonstrated knowledge of regulatory submission and approval processes.
• Proven ability to critically evaluate data from a broad range of scientific disciplines.
• Strong leadership and communication skills.

Languages

• French and fluent in English, with spoken and written ability to attend meetings and write clear reports.

Additional Skills

• Experience in the development, manufacturing, and regulatory submission of injectable pharmaceutical products.
• Experience with global regulatory submissions and Health Authority interactions.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Strong problem-solving skills and attention to detail.

Competitive Package Composed of:

• Bonus and profit sharing.
• Free shares granted by the company (MedinCell employees are also shareholders).
• Relocation assistance available.
• Lunch vouchers of 9€ per day, 60% paid by the company.
• Sport and yoga sessions onsite available 4 times a week.
• Monthly socializing events.
• Very flexible working hours and home office policy.

MedinCell is an equal opportunity employer welcoming applications from all individuals, including those with disabilities.