Associate - Regulatory Affairs

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Contract Type: Fixed Term 12 months - Agency Contract

Purpose

The purpose of the Associate Regulatory Affairs role is to manage regulatory projects/processes/activities for new and existing products respecting European and Italian Law/Regulation and Eli Lilly Corporate/Eli Lilly Italia Policy and Standard Operating Procedures (SOPs).

Responsibilities

• Acting as a primary interface with the local regulatory authorities.
• Maintaining Marketing Authorizations (i.e., renewals, variations, new indications, line extensions)
• Revision, translations, and preparation of labeling for drugs and medical devices (i.e., Summary Product Characteristics (SmPCs), Leaflets, Cartons, Labels, User manual).
• Submission to regulatory Authorities (Agenzia Italiana del Farmaco, AIFA, and Italian Ministry of Health) of any changes (technical/safety/efficacy) concerning the updating to registration dossier of Lilly products/devices.
• Responsible to communicate shortages of Lilly medicinal products to AIFA and to the European Medicines Agency (EMA).
• Responsible to manage/communicate Risk Management Plan/Risk Minimization activities and Dear Health Care Provider (DHCP) letter/Important Informative Note (NII) with AIFA.
• Providing the relevant information to the Global Regulatory Affairs-International (GRA-Intl) Scientists, performing relevant activities such as: a) Serve as link to international regulatory group; b) Voicing affiliate perspective and needs in applications to regional regulatory e.g., draft labelling; c) Providing timely response to requests from International regulatory group; d) Communicating local changes to appropriate GRA management and functional experts.
• Requiring, organizing, and approving the development/revision of the packaging materials (artworks).
• Acting as Affiliate Labeling Responsible Person (ALRP), primary, alternate and delegate.
• Being responsible for ensuring that corporate and local regulatory systems are kept updated with the appropriate information.
• Inform relevant functions about relevant regulatory product information updates (updated SmPCs, new pack design etc.).
• Ensure the safekeeping/ orderly storage of active/inactive Regulatory documentation according to Lilly Procedures, and law requirements.
• Supporting internal Divisions (i.e., Marketing, Medical, PRA – Price, Reimbursement, Access-, Legal, Commercial finance, and Affiliate Quality) for any official regulatory documentation.
• Providing external Authorities (such as EMA – European Medicine Agency, AIFA, Ministry of Health), other external Agencies (i.e., Farmadati/Pharmaceutical data banks) and Third Parties with the regulatory documentation.
• Implementing regulatory SOPs requested by Global Regulatory Affairs, local processes to ensure compliance with Lilly SOPs and Regulatory requirements.
• Act as backup of the function responsible to inspect the Regulatory mailbox of Posta Elettronica Certificata (PEC) in case of absence.

Main internal cross-functional activities

• ALRP: regulatory managing of labeling, working in collaboration with GRA-Intl and GOLD (Global Operations Labeling Department).
• Price Reimbursement Access (PRA): to provide support and collaboration to PRA Team on the preparation of the AIFA reimbursement dossier.
• MANUFACTURING SITES: to interact with Printed Packaging Material Development (PPMD), Global supply chain and Lilly manufacturing sites to agree the development/revision of the packaging materials in terms of processes, planning, implementation time and approval.
• Participate in affiliate cross-functional teams (Marketing, Medical, Affiliate Quality, Commercial finance, Legal) to deliver business objectives in compliance with local regulation and internal procedures and providing regulatory input and knowledge.

Main external relationship

• REGULATORY AUTHORITIES: to establish and maintain good relationship with local regulatory Agency, creating and maintaining contacts and proposing positive solutions for national and mutual recognition procedures.
• THIRD PARTIES: oversight of Third-Party Organizations (TPOs) for regulatory deliverables.

Minimum Qualification Requirements:

• Relevant scientific degree, preferred in medical/biological sciences (i.e., Medicine and Surgery, Chemistry and Pharmaceutical Technologies, Pharmacy, Biology) and previous experience in pharmaceutical environments.
• Good knowledge of European/National legislation with regards to relevant EU and local regulatory guidelines, directives and laws.
• Good knowledge of written and spoken English language.

Other Information/Additional Preferences:

• Proficiency in use of standard business software.
• Attitude to perform accurate activities with abilities of analysis and precision.
• Team working skills with customer focus and outcome orientation.
• Project management skills.
• Attitude to face quickly changes and implementation of new processes/procedures and tools.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

€36.370 - €53.350

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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