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Manager, Regulatory Affairs

3 mesi fa

Milano, Lombardia, Italia Pharmalex A tempo pieno

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.


Manager, Regulatory Affairs


Project Manager, strategic and operational support, principally focused on review and submission of promotional materials, and on support of companies with Marketing Authorizations of medicinal products authorized mostly according to centralized procedures in order to launch and maintain the products in Italy (local activities).


Your Job

  • Review of promotional and nonpromotional material
  • Strategic and operational customer support with company setup activities and with national requirements compliance to market medicinal products in Italy.
  • Translations and review of Product Information (Linguistic Review).
  • Management of educational materials
  • Communication with the Client and Health Authority
  • 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 sciences
  • Between 710 years of professional experience.
  • Solid experience in review and submission of promotional materials
  • Good knowledge of EU and national pharmaceutical legislation
  • Ability to analyze and solve problems and to offer solutions for a given task or project
  • Very high attention to detail
  • Project management experience and 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
  • Experienced user of the MS-Office package, Adobe Acrobat and database systems
  • English language fluency, written and spoken

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 location of the proposed job is Milan (Italy) and smart working may be an option.
For further information please don't hesitate to contact us.

Agencies only by prior agreement for the specific job opportunity.