Pelin Bozkurt

Experience

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  AbbVie

  Aug 2022 - Jul 2023

  Regulatory Affairs Intern

  •Supported the workload of the department including both AbbVie & Allergan Aesthetics portfolios.•Prepare re-registration and variation applications in order to maintain the registration of marketed products.•General licensing procedures and commission processes were learned.•Reviewed various crucial submissions (new products, variations, SPC/PIL updates, renewals, GMP, etc.) and document translations.•Variation of type IA,IB,II; licence withdrawal and license annotation submission documents were prepared•Liaised crucial health authority updates: MoH requests and responses, registered products lists, active substances lists, SPC/PIL lists and relevant announcements.•The regulations, guidelines and announcement of MoH were followed.•Tracked, analysed and liaised regulatory updates of the industry with a main focus on competitors.•Veeva Vault, which is currently used in the sector, has also been followed and updated the applications used in the company.•Learned the strategies and dynamics of the regulatory landscape of an extensive and innovative pipeline. Show less

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  Freya Cosmetic

  Jan 2023 - Feb 2023

  R&D Laboratory Intern

  •The analysis of the materials to be used in the products which are trending in the cosmeticsector was execute.•Quality control of the manufactured products was carried out.•The necessary studies were maintained to develop new products.

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  Ravago Turkey

  Jul 2023 - Oct 2023

  •Collect and analyze operational data to drive productivity.•Thermoplastic polyurethane and polyurethane production processes observations.•Identifying the process providing soliution to these problems.•Work on continuous improvement activities that help to improve the current operation processes and systems.•Actively participate in group meeting discussions and continuous improvement.•Applying lean production methods sucah as 5S in the plant.•Acquired proficiency in the operation of various analytical instruments, utilizing them to avealuate the characteristics and quality of samples.•Gained experience in various analyses, inclouding chemical aging and mechanical testing and reported finding accurately.•Through visits to the R&D department, observed innovation practices and product development process. Show less

  • Research And Development Intern - Thermoplastic Elastomers

    Sept 2023 - Oct 2023

  • Production Engineering Intern

    Jul 2023 - Sept 2023
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  Bayer

  Oct 2023 - May 2024

  Regulatory Affairs Intern

  •Prepares and submits dossier following internal approval processes for any regulatory working (variations, SPC/PIL, license annotation) to MoH.•Coordinate regulatory activities in project, attend calls with global contact, my manager and 3rd party manufacturing sites, prepare the documents to submit application on time.•Participate the training with the global technical team and presentation to regulatory team.•Tracked, analysed and liaised regulatory updates of the industry with a main focus on competitors.•Veeva Vault has also been followed and updated the applications used in the company. Show less

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  AbbVie

  May 2024 - now

  Regulatory Affairs Specialist