We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

Office located in Milano, but working remotely is a possibility

Senior Specialist, Regulatory Affairs

You will be responsible for assisting the project leader in all aspects of office and project management and in operational tasks within the management of activities of concomitantly several Marketing Authorization Holders of medicinal products authorized principally according to centralized procedures.

Your Job

Under adequate supervision of the project leader: 
  • Communication with the Client and Health Authority
  • Customer support with company set-up activities and with national requirements compliance to market medicinal products in Italy in particular but not only:
    • Request of SIS code
    • Preparation and Submission of Power of Attorney
    • Preparation and Submission of Legal Representation
    • Management of congresses in AIFA portal
    • Accreditation and maintenance of sales representatives with Regions
    • Yearly and six-monthly communication of data regarding sales reps to Italian Medicines Agency and to Regions
    • Registration of companies in IPZS portal and ordering of bollinis
    • Management of PILs and Labels for the Bolzano Province
    • Preparation of various kinds of communications and submission via certified mail or via AIFA portal
    • Support to client for declaration of yearly promotional expenses
    • Support to client for annual fee payment
    • Management of Farmastampati
    • Management of shortages in AIFA portal
    • Preparation of traceability communications to be submitted to Italian MoH
    • Publications in Official Gazette
    • Submission of promotional materials via AIFA portal
    • Update of drug-listing databases with new PI
    • Preparation of Transfer of Value documentation
    • Monitoring of AIFA portal and download of documentation regarding payback and provision to client with guidelines for payment
  • Translations and review of Product Information
  • Management of educational materials
  • Support the review of promotional and non-promotional material
  • Prepare, submit and gain approval for regulatory applications to Regulatory Agencies. Assess and respond to regulatory questions to resolve issues (e.g. submission of MRP/DCP variations/renewals via AIFA portal)
  • Execute activities, monitor progress until end of project
  • Be flexible to respond to any kind of client demands (also outside strict regulatory framework) according to required timelines.
  • Travel to client meetings as required by the business or participate in TCs.
  • Develop and maintain a thorough knowledge of European and national regulatory requirements.
  • Maintain the Company’s values and work ethos
  • Maintain internal department templates
  • Participate in archiving activities
  • Careful contribution to control time tracking sheets for invoicing purposes

Your Profile

  • University degree in pharmacy or other natural or life sciences
  • Good knowledge of EU and national pharmaceutical legislation
  • Experienced user of the MS-Office package, Adobe Acrobat and database systems
  • English language fluency, written and spoken
  • Ability to analyze and solve problems and to offer solutions for a given task or project.
  • Very high attention to detail
  • Strong service orientation
  • Autonomous approach to work, flexibility and dedication
  • Strong sense of responsibility, organizational skills and intrinsic motivation
  • Excellent team player
  • Professional written and spoken communication skills with internal and external customers, colleagues and supervisors
  • Diplomacy, ability to communicate and fit in an international and multicultural environment

We offer

  • An opportunity to work within an organisation with a positive work/life balance environment , one of the leading service companies for the Pharmaceutical Industry globally, in which our values are the backbone of our company, i.e. international mindset, growth and learning, collaboration, quality focus, dynamic working approach and integrity and respect.
  • The role may be carried out, when possible, depending on the needs of the client, also totally smartworking. The location of the proposed job is Milan (Italy).

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:

Jorge Castillo
Senior Specialist, Corporate Talent Acquisition


Agencies only by prior agreement for the specific job opportunity.