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.
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.
Regulatory Operations ManagerMölndal, 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 AssistantMölndal, 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
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
- 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.
- 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.
- 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.
- 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.
Project Leader | ManagerApril 2015 --- February 2016
- 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
- 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 ConsultantJuly 2015 --- August 2015
- Pharmacovigilance studies for an orphan drug developed to treat wilson´s disease
- comparative drug Analysis, interpretation and graphing data from pre clinical studies
- discussions and Presentations with the medical and Regulatory Affairs team
- 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 NeuroscienceOctober 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 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.
Industrial Brewer (Trainee)December 2007 --- June 2008
learnt basic concepts and techniques of industrial brewing.
Analytical thinkingApproachabilityAttention to detailAuthenticityCollaborationCommunicativeCompetitivenessCoordinationCritical thinkingCuriosityDependabilityFlexibilityIndependenceProactivityProblem solvingResult OrientedSociabilityInterest in knowledgeAdaptability
BiotechnologyNeuroscienceDrug Safety and PharmacovigilanceUnderstanding of regulatory guidelines Scientific writingMolecular & Cellular BiologyAnimal ModelscGMPData AnalysisDrug development processDrug InteractionDrug metabolismEnglishEvent Managementgrant writing and design
Skills and Expertise
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
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
Expert has 4 publications (Will be avalible with full profile)