We are growing, grow with us!
Are you looking for a dynamic company with daily challenges and opportunities?
Then, Pharmalex is your next career move! Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally, specialised in all aspects of drugs and medical devices approval of the market development, and any action of effective product maintenance.
Regulatory Affairs Manager
Project Manager, strategic and operational support, principally focused on regulatory processes to gain and maintain Italian marketing authorizations for human medicinal products (MAA, renewal, variations), review and submission of promotional materials, support for company set-up with AIFA to support product launch and regulatory maintenance of the products in Italy.
- Prepare, submit and gain approval for regulatory applications to AIFA (MAA, renewal, variations). Assess and respond to regulatory questions to resolve issues. Management of post-approval activities as required.
- Review and submission (where applicable) of promotional and non-promotional materials.
- Strategic and operational customer support with company set-up activities and with national requirements to market medicinal products in Italy.
- Translations and review of Product Information (Linguistic Review).
- Management of activities related to educational materials.
- Communication with Clients and Health Authorities.
- Project Management, execution of activities, progress monitoring until end of project.
- Advisor to Clients on regulatory procedures and requirements in consultation with senior management.
- Advisor to Clients on strategic issues based on experience and knowledge in consultation with senior management.
- Flexibility to respond to client demands (also outside strict regulatory framework) according to required timelines.
- Travel to client meetings as required or participation in TCs.
- Develop and maintain a thorough knowledge of European and national regulatory requirements.
- Maintain the Company’s values and work ethos.
- Participation in archiving activities.
- University degree in pharmacy or other natural sciences
- 7-10 year experience in Regulatory Affairs department
- Solid experience in review and submission of promotional materials and life-cycle management activities with AIFA
- Project management experience
- 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
- High service orientation, flexibility, strong sense of responsibility, organizational skills, autonomous approach to work, ability to process parallel projects and tasks, self-motivation
- Excellent team player
- Professional written and spoken communication skills with internal and external customers, colleagues and supervisors, ability to fit in an international and multicultural environment
- Ability to manage internal and external (client) relationships on operational as well as client’s team lead level
- Experienced user of the MS-Office package, Adobe Acrobat and database systems
- Italian language is a must; Fluent English, both 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.