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.
Regulatory Affairs Support
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.
- 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
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.
Agencies only by prior agreement for the specific job opportunity.