The Italian RA Product Lead provides regulatory support for assigned Shire product franchises within the local operating company (LOC). Primary responsibilities include operational regulatory affairs activities, involving interface from LOC to Global RA, ensuring conformance to Italian and EU Drug Legislation, maintaining labelling information to internal and external partners, communicating with regulatory authority when requested and regulatory institutions, supporting internal Global RA, other R&D departments and providing collaborative support for commercial teams. Approval of specific advertising and promotional materials in accordance with national legislation and code of practice. Responsibilities include ensuring adherence to company standards and local laws.
1) National Regulatory authority interactions (40%):
LOC manages direct interactions with Italian regulatory authorities for national licenses and for the national phase of MRP/DCP procedures and may facilitate interactions by the EU RA strategists in the case of centralized procedures where the Italy is the rapporteur/co-rapporteur, or where Italy is Reference Member State.
Regulatory contact point for local, international and global cross functional teams on Italian matters
- Provide regulatory advice to support the Italy business strategy. Ensure in conjunction with Italy/Greece Regulatory Cluster Lead that regulatory requirements of Italy are fully represented in discussions at Global, Regional and Local levels.
- May support EU strategy on specific projects on development/marketed products. Support and align with other departments/functions on needs re periodical requests. (e.g., tender support and HTA submissions). Provide local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the agency or review of national requirements. With support of QA/Compliance may participate in drawing up and monitoring Company standard operating procedures, as well as checking on their application, in cooperation with superiors
- May participate in drawing up and monitoring specific RA department company standard operating procedures.
Scientific advice meetings
- Facilitate preparation for scientific advice meetings with national agencies.
- Launch readiness and other commercial project team support
- Provide regulatory input to Health technology appraisal/ horizon scanning for product portfolio
- Product tender and pricing application support, including PPRS
- Provide regulatory guidance and make relevant submissions for Early Access Medicines Scheme (EAPs)
- With PV proactively assess any Risk minimization activities in RMS and engage with national regulatory authorities to gain approval of Risk minimization measures / educational materials
Clinical trial applications (in cases where CTA submission has been agreed to be handled in-house through LOC):
- May submit PASS protocols to the national regulatory authorities in collaboration with EU RA Strategist.
- May be involved in clinical trial submissions for interventional company sponsored clinical trials.
2) Product Labeling (20%):
- Responsible for providing the consolidated feedback regarding the text translation from the relevant functions in the affiliate to the EU Regulatory Strategists
- Responsible for updating all local health authority or non-health authority prescribing information / SmPC databases (where exist) and compendia (e.g Drafting monographs for medical reference dictionaries)
- Liaise with marketing and commercial to ensure that all local product information used are up to date
3) Proactively monitor national regulatory landscape (5%):
- Monitor drug regulations at the national levels and distributing information to the departments concerned;
- Monitor competitor registration landscape where requested and distribute information to the departments concerned;
- Develop professional and effective working relationships with AIFA
4) Advertising / promotion (35%):
- Review promotional materials and patient support materials on Shire products according to Italian law and applicable codes of practice and Shire International procedures.
- Facilitate any necessary submission of advertising to AIFA
- Ensure the creation and update of prescribing information with support from Medical Affairs
On behalf of the MAH:
- ensure regulatory compliance in country in accordance with local regulations and Shire SOPs.
- Participate in local review teams and work to local regulations / requirements/codes for the review of local promotional and non-promotional materials per Shire International SOP, as well as to check compliance with Shire standards for Global Safety Information requirements
- Provide advice to LOC team, International Commercial, on maintaining compliance of Shire materials with local regulations/requirements codes at any International symposia/conferences to be held in their country.
- Responsible for bringing to the attention of R&D Compliance/Quality Assurance any planned local SOP or local SOP revision, which they are aware of, and which relates to R&D activities
Responsible for immediately notifying R&D Compliance/Quality Assurance of any planned health authority inspection relating to R&D activities and will work with R&D Compliance/Quality Assurance to prepare for the inspection, receive/host the inspection, and respond to findings.
Education and Experience Requirements
BS/MS in a scientific discipline. Ph.D. or Pharm.D preferred.
Minimum 8 years of experience with multinational companies in regulatory affairs
Proven experience and relationship with Italian Regulatory Authorities
Key Skills, Abilities, and Competencies
Good communication skills
Good negotiation skills
Deep knowledge of regulatory scenario
Complexity and Problem Solving
Proactive and initiative, strong interpersonal skills; supports business priority; sense of urgency; able to work with minimal supervision in a pressurised environment; effectively manage multiple competing tasks. Works under general direction.
Internal and External Contacts
Internal and external job contacts related to the position include Shire counterparts, project team members, cross functional teams, senior management, regulatory agency personnel, and company consultants/vendors/distributors.
Other Job Requirements