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Summary

i am an experienced professional in Regulatory Affairs, Medical writing, Research and Project Management. my Career objective is to create a positive impact on society by ensuring development of safe & efficacious medicinal products by contributing to vital regulatory functions such as Project Management.

 

my experience ranges from leading international Career events to Drug Development and reviewing of regulatory documents. today, i am passionate to explore more possibilities in Regulatory Affairs and contribute to solutions for future challenges in the field. Regulatory Affairs being a dynamic field that combines science and Project Management, keeps me motivated to learn more, take on new challenges and grow professionally.

 

as a person with good international study and work exposure, i quickly embrace change and welcome the opportunity to be creative, Problem Solving and collaborative.

 

Career goals

after having gained experience in Regulatory Affairs and Drug Development, i am now seeking to broaden my understanding of the field and take on a role with greater responsibility.

 

i believe that an exciting and challenging position within Drug Development will be a great opportunity where i can utilize my previous experience, learn further and develop in a direction where i can participate in key functions and contribute to the growth of the team i am associated with.

Experiences

Current Experience

  • Regulatory Operations Manager

    Mölndal, Sweden
    Since June 2018
    • primary duty is to provide expertise in end-to-end document and submission publishing of various regulatory documents 
    • ensure that all regulatory documents meet the technical and formatting requirements set by Health authorities such as the FDA and EMA
    • system administration of validated Applications in a regulated environment
    • analyse queries from user community to identify improvement opportunities in systems, cue cards, Training materials and Business Process
    • provide overall support to other regulatory-related functions such as cmc and Patient Safety 
    • Primary duty is to provide expertise in end-to-end document and submission publishing of various regulatory documents 
    • Ensure that all regulatory documents meet the technical and formatting requirements set by Health Authorities such as the FDA and EMA
    • System administration of validated applications in a regulated environment
    • Analyse queries from user community to identify improvement opportunities in Systems, Cue Cards, Training Materials and business process
    • Provide overall support to other regulatory-related functions such as CMC and Patient Safety 

  • Global Labeling Proofreader/Regulatory Affairs Assistant

    Mölndal, Sweden
    Since October 2017
    • contribute to labelling/regulatory submissions to FDA and EMA
    • ensure proper version control and document integrity of Packaging component labelling artworks and other assigned labelling documents (ndas, ctas and maas)
    • assist in maintaining repository of current labelling of documents and with uploading documents to electronic Document Management sysyems such as angel and alice
    • review product labelling galley proods for the Physician's desk reference
    • participate in the development and maintanence of work practices, templates and associated documents realting to the labelling function (uspis, smpcs etc)
    • contribute to regulatory Strategy Planning and assist in regulatory dossier management
    • Contribute to labelling/regulatory submissions to FDA and EMA
    • Ensure proper version control and document integrity of packaging component labelling artworks and other assigned labelling documents (NDAs, CTAs and MAAs)
    • Assist in maintaining repository of current labelling of documents and with uploading documents to electronic document management sysyems such as ANGEL and AliCE
    • Review product labelling galley proods for the Physician's Desk Reference
    • Participate in the development and maintanence of work practices, templates and associated documents realting to the labelling function (USPIs, SMPCs etc)
    • Contribute to regulatory strategy planning and assist in regulatory dossier management

  • Consultant

    Stockholm, Sweden
    Since May 2017
    • as a Lab Technician responsibilities include storage, withdrawal and shipment of various Biological samples
    • extraction of Biological samples such as DNA on automated/robotic systems
    • update LIMS system and maintenance of robotic systems
    • carry out Aseptic Lab procedures for Cell cultures and ensure safe/sterile conditions for Biological samples
    • As a Lab Technician responsibilities include Storage, Withdrawal and Shipment of various biological samples
    • Extraction of biological samples such as DNA on automated/robotic systems
    • Update LIMS system and maintenance of robotic systems
    • Carry out aseptic lab procedures for cell cultures and ensure safe/sterile conditions for biological samples

  • PhD Student in Molecular Neuroscience (André Fisahn Lab)


    Since October 2012

    responsibilities

    key achievements

    • received travel grants and gained experience in grant application, Medical writing and scientific Communication.
    • co patentee of a drug related to preventing ad in the european patent office (epo).
    • basics in Pharmaceutical Regulatory Affairs course- topra, london, uk.
    • knowledge of ich gcp guidelines, acquisition and management of pre-clinical and clinical data.
    • Clinical trials in the nordic countries conference by läkemedelsakademin (15 and 16 june, 2016).
    • authored 5x papers in reputed journals including nature and presented work at international conferences.

    Responsibilities

    • Design and implement pre clinical therapeutic studies for AD and developed SOPs
    • Good laboratory practice, good documentation practice and lab management
    • Extensive literature reviews, graphing of scientific data and medical communication.

    Key achievements

    • Received travel grants and gained experience in grant application, medical writing and scientific communication.
    • Co patentee of a drug related to preventing AD in the European Patent Office (EPO).
    • Basics in pharmaceutical regulatory affairs course- TOPRA, London, UK.
    • Knowledge of ICH GCP guidelines, acquisition and management of pre-clinical and clinical data.
    • Clinical trials in the Nordic countries conference by Läkemedelsakademin (15 and 16 June, 2016).
    • Authored 5X papers in reputed journals including Nature and presented work at international conferences.

Past Experience

  • Project Leader | Manager

    April 2015 --- February 2016

    responsibilities

    • lead the team for a stimulating global Career fair, chase 2016, designed to create network opportunity for students and the phamaceutical industry
    • directly managed a team of 12 members and 40 volunteers and delegated tasks
    • Public Relations, interaction with pharma companies worldwide, financial, Logistics, Marketing and Event Management

    key achievements

    •  established a strong network of global Life Sciences companies and academia and facilitated better collaborations
    • developed effective interpersonal skills, a good customer base and management skills
    • the event constituted over 25 Life Sciences company exhibitors, Presentations and workshops and was attended by 1000+ visitors and helped create several collaborations. http://chasesthlm.se/

  • Research Intern and Consultant

    July 2015 --- August 2015

    responsibilities

    key achievements

    • Pharmaceutical regulatory and medical affairs management
    • knowledge of ich gcp guidelines and Clinical Data Management
    • submitted a comprehensive white paper on the mode of action and Pharmacovigilance of the proprietary drug and other competing drugs
    • the white paper formed the literature basis for drug approval application at the FDA

  • Research Student of Molecular Neuroscience

    October 2011 --- September 2012
    work involved handling Laboratory animals, dissecting brain, perfusing them and identify various brain structures in microscopes, identify fluorescently labelled neuronal subtypes and electrophysiological recordings and Analysis.

  • Research Student of Molecular Neuroscience (Björn Granseth Lab)

    September 2010 --- September 2011
    Electrophysiology and confocal imaging studies of beta-amyloid peptide transmission capability in cellular cultures- showing a putative mechanism for Alzheimer's disease progression (an invitro study).

  • Research Student of Computational Neuroscience (Fredrik Elinder Lab)

    January 2010 --- June 2010
    study was to find a binding site for a polyunsaturated fatty acid on a voltage-gated ion channel, and to calculate action potentials of a thalamic relay neuron to explore the effects the polyunsaturated fatty acid on the electrical activity.

  • Research Student of Computational Neuroscience

    December 2008 --- July 2009
    work involved homology modelling to predict structure of a disease (epilepsy) associated Protein and molecular docking of the Protein to a known ligand Molecule and analyze the structure.

  • Intern at Microbiology Department

    November 2008 --- February 2009
    microbial staining and streaking to identify microbes responsible for various diseases as a part of routine Hospital Analysis.

  • Industrial Brewer (Trainee)

    December 2007 --- June 2008
    learnt basic concepts and techniques of industrial brewing.

Personality

Self Assessment :
Analytical thinkingApproachabilityAttention to detailAuthenticityCollaborationCommunicativeCompetitivenessCoordinationCritical thinkingCuriosityDependabilityFlexibilityIndependenceProactivityProblem solvingResult OrientedSociabilityInterest in knowledgeAdaptability

Knowledge

Self Assessment :
BiotechnologyNeuroscienceDrug Safety and PharmacovigilanceUnderstanding of regulatory guidelines Scientific writingMolecular & Cellular BiologyAnimal ModelscGMPData AnalysisDrug development processDrug InteractionDrug metabolismEnglishEvent Managementgrant writing and design
LinkedIn Assessment :
molecular biologyLife SciencesConfocal MicroscopyElectrophysiologyCell CultureCell biologyResearchScientific WritingBiotechnologyProject ManagementMarketingPublic RelationsComputational NeuroscienceClinical researchMicrobiologymanagement

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Create SOPs Interpret data Write papersAttend seminars, courses and meetings within and outside the companyAlzheimerdrafting grant applicationsWrite statistical reportsWrite medical reportsWrite papersRegulatory submissionsWriting regulatory documentsManage regulatory activitiesDevelop regulatory strategy

Education

  • Masters in Medical Biosciences in Human health and diseases; From cellular to clinical aspects from Linköping University in 2011
  • Bachelor of Technology (BTech) in Biotechnology from Vellore Institute of Technology in 2009

Training and Certification

  • Basics in pharmaceutical regulatory affairs (TOPRA) in 2016 Certification
  • Clinical trials in Nordic (Läkemedelsakademin) in 2016 Certification
  • Advanced Neuroscience (NSAS) in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Swedish
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Trial Assistant (CTA) Clinical Research Associate (CRA) Regulatory Affairs Assistant Medical Science Liaison (MSL) Clinical Data Reviewer Medical Writer Molecular Biologist Scientific consultant
  • Locations I am interested in:
    Denmark Finland Norway Sweden
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Publications

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

Area / Region

Mölndal, Västra Götland, Sweden

Others

Driving License
  • No

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