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.
Senior Specialist, Regulatory Affairs
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).
- Review of promotional and non-promotional material
- Customer support with company set-up activities and with national requirements compliance to market medicinal products in Italy.
- Translations and review of Product Information (Linguistic Review).
- Management of educational materials
- 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)
- 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
- University degree in pharmacy or other natural sciences
- 5-year 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
- 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
- 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.
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.
Agencies only by prior agreement for the specific job opportunity.