Marcella Albanti

• Dossier writing, variation submission management, Regulatory management of changes in manufacturing facilities
• In charge of regulatory compliance role: monitor and provide management with impact of changes in Regulatory environment
• Streamlined submission processes for improved efficiency and timely approvals from regulatory agencies.
• Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
• Oversaw timely preparation and submission of high-quality documentation for product registrations and renewals.
• Championed cross-functional collaboration by establishing regular meetings with relevant departments, ensuring seamless project execution.
• Evaluated emerging legislation and its potential impact on current products or future developments.
• Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
• Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
• Trained staff in regulatory policies or procedures.
• Provided responses to regulatory agencies regarding product information or issues.

• API drugs DMF writing, DMF part of veterinary dossiers, changes submission.

Lifecycle management of authorized DMF, DMF writing, maintenance old licenses (API)

• Preparation of documentation to get CEP/CEP updating
• ANDAs, ANDS deficiency responses
• (EU, US, Canada, China, Korea, Brazil, GCC countries) Customer regulatory documents Management In charge of t regulatory compliance role: monitor and provide management with impact of changes in Regulatory environment
• Establish strong relationship with Health Authorities, including follow-up to check submission status Florida Permit management
• Daily contact with other functions and with same function around world (customers)
• Daily contact with other functions and with same function around world (customers)

• Lifecycle management of authorized DMF, DMF writing, maintenance old licenses
• Preparation of documentation to get CEP/CEP updating
• ANDAs, ANDS deficiency responses
• In charge of regulatory compliance role: monitor and provide management with impact of changes in Regulatory environment
• Establish strong relationship with Health Authorities, including follow-up to check submission status Daily contact with global function and with same function around world inside company
• Providing documents for registration of products to several companies around world
• Regulatory representative in several cross-functional cross-site projects.

• Management of drug parallel import license (AIP) Medical Device (class I) registration (Italy) Cosmetic products registration
• Management of cosmetic products marketing brochures
• Post marketing assistance medical device as customer service

• Orphan Drug Designation (ODD) request (EMA) Participate to Combined Product (FDA) application, development new MAAs OD, maintenance old ODD
• IB and IMPD new Orphan Drug Attend Scientific Advice with competent authorities.

• Flu Franchise, construction module 1 of the CTD and e-CTD, for EU, Swiss, Canada, Kazakhstan, Poland, Hungary, Croatia, Albany, Moldova, Russia, Serbia/Montenegro, Czech Republic
• Submission of variations (IA, IB, II) and renewal of MA, support in control of documents of Module 2 and 3 for the submissions
• MRP/DCP/National procedures
• Daily interaction with CA in EU member states.

• Information of the Practitioners and Specialists