CMC Regulatory Affairs Specialist

We provide pharmaceutical and life science companies with the strategic in-market and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets.

The ideal candidate will join the Regulatory Affairs - Drug Development team and will provide support in managing CMC (Chemistry Manufacturing and Controls) regulatory aspects throughout all phases of the product lifecycle from development to post-marketing.

The role will focus on regulatory strategy definition preparation and review of CMC documentation ensuring compliance with global regulations and liaising with regulatory authorities and clients to address their specific needs.

Key Responsibilities:

• Provide strategic regulatory advice on CMC aspects for pharmaceutical biotech products and advanced therapy medicinal products (ATMPs).
• Draft review and manage CMC documentation for national and international submissions (IMPD IND NDA BLA MAA DMF CEP and post-approval variations).
• Support clients in preparing IMPD DS and DP modules and CTD Module 2 (Quality Overall Summary) and Module 3 (Quality).
• Manage communication with regulatory authorities assisting clients in preparing responses to requests for clarification scientific advice and approval strategies.
• Monitor global CMC regulatory requirements and provide clients with updates on new ICH EMA FDA and WHO guidelines and regulations.
• Support the management of CMC regulatory variations.
• Collaborate with internal and external cross-functional teams providing regulatory expertise to clients during the development and registration of new products.
• Participate in client meetings to define tailored regulatory strategies and optimize submission processes.
• Contribute to the preparation of gap analysis risk assessments and regulatory due diligence for products in development or already marketed.

Essential Requirements:

• Degree in Chemistry Pharmaceutical Chemistry and Technology (CTF) Biotechnology Pharmacy or related scientific disciplines.
• At least 3-5 years of experience in CMC Regulatory Affairs.
• Knowledge of ICH EMA FDA and WHO regulatory requirements and key CMC guidelines.
• Experience in the preparation and review of CTD and eCTD - Module 3.
• Ability to interact with international clients and provide tailored regulatory solutions.
• Excellent command of English (written and spoken).
• Project management experience.

Nice to have:

• Basic knowledge of GMP principles within pharmaceutical manufacturing environments.
• Familiarity with GMP-related documentation and processes as supporting elements for CMC regulatory activities.
• Previous exposure to GMP-regulated contexts through collaboration with Quality or Manufacturing teams.
• Participation in GMP audits.

Soft Skills:

• Strong communication and stakeholder management skills with the ability to interact effectively with clients regulatory authorities and cross-functional teams.
• High attention to detail and structured working approach ensuring accuracy and consistency across regulatory documentation and submissions.
• Strong organizational and problem-solving skills with the ability to manage multiple projects and priorities in a dynamic regulatory environment.

Contract details:

• Type: Permanent
• Location: Pisa or Milan
• Hybrid work

Benefits:

• 10 meal voucher per on-site working day
• Competitive corporate welfare plan
• Birthday leave

The selection respects Legislative Decree 198/2006 and is open to candidates of any orientation or expression of gender sexual orientation age ethnicity and religious belief. This announcement is designed to respect diversity and inclusiveness.