Execution of operational tasks - mainly under professional instruction - in the field of Regulatory Submissions which require expertise in the natural sciences with main focus on life sciences or chemistry.
May assist project and line leaders with aspects of office, contract and project management.
- Support with project work (e.g. compilation, preparation and reviewing of submission specific documents).
- Thereby strong emphasis on relevant technical and regulatory requirements and customer specific demands.
- Support in regulatory procedures to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations, country specific procedures) with emphasis on Brazil and LATAM aspects.
- Support in preparation of the informative texts for healthcare professionals and patients (SmPC, PL, labelling).
- Conduct of technical database, internet and literature searches with preparation and evaluation of the search results; review and evaluation of technical literature.
- May support communication with clients and partners.
- If applicable support in preparation, quotation and invoicing for Regulatory Affairs Projects in close cooperation with the respective team lead
- Assist in optimizing and monitoring internal departmental organization:
- Maintain internal departmental templates
- Assist the project managers in project planning and organization of meetings.
- Assist the line management and teams
- May present at seminars and lectures PHARMALEX-internally with emphasis on Brazil and LATAM aspects.
Critical qualifications, experience, ‘know-how’ and skills
University degree in pharmacy
Basic (min. 2 years) experience of area of activity or similar field
- Structured, analytical and systematic way of working
- Ability to work according to project plan/given instructions and escalate potential issues according to agreed communication plan
- Ability to prioritize and manage own time and tasks
- Ability to manage internal and external (client) relationships on operational / day-to-day working level.
- Good written and spoken communication skills; Confident appearance.
- Excellent team player
- Attention to detail. High service orientation
- Experienced in using the MS-Office package
- English language language fluency, written and spoken
- Spanish language is highly desirable