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Summary

i am ready and highly motivated to face a new challenge, to take advantage of my knowledge, strengths and abilities, to share ideas and gain something new. i am trustworthy, self-motivated and committed to the work i do.

the last years were significant for my self-development, demonstrating good skills in adapting to new working environments. i have been developing my regulatory knowledge by getting more familiar with regulations, guidelines, procedures and policies (chemical sector - past; Pharmaceutical sector - current). being exposed to diverse tools, Software, established ways of working and being responsible for different tasks/projects let me gain a good level of Flexibility and confidence at work. i proved to learn very quickly and work independently. i established good relationships with colleagues from different areas of work. my enthusiasm, attention to details, Problem Solving attitude, and good Communication Skills are always appreciated.

as a creative, open - minded, flexible, able to cope under pressure person i would do my best to be an effective Employee and a good colleague.

 

Experiences

Current Experience

  • Junior Regulatory Specialist

    Poznań, Poland
    Since January 2014

    support for gsk global cmc regulatory department in regulatory activities reflected in preparation of appropriate cmc components for global regulatory dossiers - support given to the global post approval registration department:

    • preparation of global cmc (Chemistry manufactury & controls) variation dossiers;

    • preparation of license renewal dossiers in irf and ctd formats (including renewals of ucb and stiefel products) - recognition award received in april 2015 for valuable input and help in meeting the challanging objective of eliminating cmc renewals backlog (certificate upon request);

    • preparation of upgrade dossiers;

    • preparation of response to questions (received from reguatory authorities) and post approval commitment dossiers.

     

    Support for GSK Global CMC Regulatory department in regulatory activities reflected in preparation of appropriate CMC components for global regulatory dossiers - support given to the Global Post Approval Registration department:

    • Preparation of global CMC (Chemistry Manufactury & Controls) variation dossiers;

    • Preparation of license renewal dossiers in IRF and CTD formats (including renewals of UCB and Stiefel products) - Recognition award received in April 2015 for valuable input and help in meeting the challanging objective of eliminating cmc renewals backlog (certificate upon request);

    • Preparation of upgrade dossiers;

    • Preparation of Response to Questions (received from Reguatory Authorities) and Post Approval Commitment dossiers.

     

Past Experience

  • Scientific Assistant Helsinki, Finland

    August 2012 --- December 2013
    • assessment of substance identification information in dossiers submitted under different processess (inquiry dossiers, registration dossiers) according to the reach regulation and annexes;

    • Analysis of submitted information for conformity and preparation of Communication letters (certified initiating agent);

    • updating and adding entries to the ec number list database;

    • contribution to the development of the Knowledge Management tool (wiki library);

    • contribution to the Testing of a decision support tool for substance identification assessment (odyssey);

    • contribution to the Testing of jchem;

    • contribution to the development and preparation of echa user manuals

     

  • Trainee Helsinki, Finland

    February 2012 --- July 2012
    • assessment of substance identification information in dossiers submitted under different pocessess (inquiry dossiers, dossiers under the evaluation process);

    • contribution to the design and development of support tools for the activities of the unit (e.g. database of chemical structures).

     

  • Trainee Budapest, Hungary

    November 2010 --- October 2011
    • studying the system of reach, making the pre-registration of chemicals;

    • working on the English version of web page of kat-chem ltd;

    • everyday Sourcing product suppliers, trading with foreign companies.

     

Personality

Self Assessment :
Attention to detailAuthenticityApproachabilityAdaptabilityAnalytical thinkingCreative thinkingCuriosityFlexibilityIndependenceInterest in knowledgeKindnessResponsibilitySelf-discipline

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Elementary Proficiency
Finnish
Elementary Proficiency
Polish
Native

Work Preferences

  • Notice Period:
    2 weeks
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Area / Region

Poznań, Poland

Others

Driving License
  • Yes

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