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Summary

Hi, I am Milica! ★ I am a pharmacist with a rich and diverse regulatory, pharmaceutical and pharmacological background and a strong interest in pharma-business. ★ Working on my PhD degree taught me not only to be a pharmacology expert and how to critically assess and present a drug information, but also how to act strategically and timely, and within the budget and independently deliver results and give a meaning to them. This have resulted in the development of a valid animal model of disease, offering novel platform for new drugs testing. ★ I am experienced communicator of complex scientific information to a multidisciplinary audience having presented at 10+ international and national conferences and having authored of 4+ publications. ★ I am able to view the things from a regulatory perspective: have submitted 4+ new drug applications for marketing authorisation and maintained a lifecycle of 10+ marketed medical products. ★ I am looking for a challenging position in which I would stay at the forefront of the scientific development and innovations in a more outward-facing, strategic role and where my work would have a global influence! By making a strong scientific arguments and analysing data in support of novel products I can be a bridge between drug development and commercialisation, or help with identification of opportunities that will push the drug development forward and drive the regulatory processes further. Let’s connect - milicazmaksimovic@gmail.com

Experiences

Past Experience

  • Pharmacology Post-Doc Researcher
    February 2015 --- July 2015
    ★ Tested the antipsychotic properties of cannabidiol in a novel mouse model of psychotic disorders

  • Pharmacology researcher Institute of Biomedicine, Department of Pharmacology
    August 2010 --- July 2015
    ★ Main research methods and techniques: Behavioural testing Test batteries Immunohistochemistry In situ hybridization Small animal magnetic resonance imaging Genotyping, PCR Brain dissection Rodent surgery Microscopy GTP autoradiography Antipsychotics Mood stabilisers Antiepileptics

  • Regulatory Affairs Associate
    March 2009 --- August 2010
    ★ Planned Submission and Management of the new products: Compiled documents and submitted application documentation for regulatory approval for 4+ new medicinal products in CTD format ★ Ensured regulatory maintenance of marketed products: 10+ variations and renewals ★ Ensured that all marketed products in the country are in compliance that meet local and corporate regulatory requirements: Prepared the local SmPC and PIL, and primary and secondary packaging layout in order to ensure their accuracy from medical, regulatory and technical point of view ★ Provided regulatory Inputs and feedback into registration strategy for new products ★ Ensured Regulatory Compliance, followed national and international regulatory legislation ★ Collaborated and established a network with business partners, communicated with the National Drug Agency (Alims), responded to authority questions;

Personality

Self Assessment :
IndependenceSelf-disciplineAttention to detailOrganizationProblem solving

Knowledge

Self Assessment :
evaluation and interpretation of scientific and medical information data management (including statistical analysis)Medical and scientific writing regulatory submissionsCNSGlobal Regulatory Strategy for PharmaceuticalsRegulatory Due Diligence for Product DevelopmentProject Management for Regulatory ProfessionalsRegulation of US and EU BiologicsEU RegulationsPharmacovigilance
LinkedIn Assessment :
pharmacologyRegulatory affairsPharmaceutical IndustryPharmaceuticsIn VivoNeuroscienceAnimal ModelsPre-clinical StudiesData AnalysisDrug DevelopmentSchizophreniaBipolar disorderRegulatory submissionsRegulatory RequirementsRenewalsVariationsPCRLife SciencesGeneric DrugsClinical trialsProject ManagementMicrosoft OfficeSPSSImage JImmunohistochemistryProject Management

Skills and Expertise

Self Assessment :
Medical writing (Academic Writing and Editing) Business management (Communication and negotiation skillsEnjoy the entrepreneurship: Bring your idea to lifeproject managementBusiness Cases for Hermo Pharma) Clinical research (Introduction to Clinical researchData Management for Clinical Research (Vanderbilt Universityhttps://www.coursera.org/account/accomplishments/certificate/ 7J48WLAHLF)Design and Interpretation of Clinical Trials (Johns Hopkins Universityhttps://www.- coursera.org/account/accomplishments/certificate/2QQ2SNCG4Z)clinical research

Education

  • Regulatory Affairs Certificate: Pharmaceuticals in from Regulatory Affairs Professionals Society in 2016
  • Doctor of Philosophy (PhD) in Pharmacology from Faculty of Medicine, University of Helsinki in 2015
  • MPharm in from Faculty of Pharmacy, University of Belgrade in 2009

Training and Certification

  • Data Management for Clinical Research in 2015 Training
  • Design and Interpretation of Clinical Trials in 2015 Training
  • Regulatory Affairs Certificate: Pharmaceuticals in 2016 Certification
  • Basics of Health Economics Certification
  • C-category FELASA accredited competence holder: license to perform animal experiments according to European legislation Certification
  • Data Management for Clinical Research Certification
  • Design and Interpretation of Clinical Trials Certification
  • ICH Good Clinical Practise Certification
  • Licensed pharmacist Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Serbian
Native
Spanish
Professional Proficiency
Portuguese
Professional Proficiency
Swedish
Elementary Proficiency
German
Elementary Proficiency
Finnish
Professional Proficiency
French
Elementary Proficiency

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Publications

    Expert has 4 publications (Will be avalible with full profile)

Area / Region

Helsinki, Finland

Others

Driving License
  • Yes