Curriculum vitae

PERSONAL DATA

Name: Bădescu Nicoleta Nadia

Nationality: Romanian
Date of birth: 24/04/1974
Marital status: married, 2 children
Address: Bucharest, Aleea Callatis Street, No.7
Telephone: 0723248394

OBJECTIVE

o I want to collaborate with people with other expertise in order to deliver high quality
healthcare services, achieved by continual improvement in terms of customers’
expectations. The aim of continuous quality improvement is to meet the customer, not
just the competition.

EDUCATION

o 1988 - 1992 – "Ioniţă Asan" High school – Caracal

o 1992 – 1997 - Faculty of Chemistry – University Bucharest
o 1995- 2000 – Faculty of Medicine – FKT section – University of Medicine and
Pharmacy Bucharest

PROFESSIONAL EXPERIENCE
o Regulatory Affairs Consultant for Novo Nordisk – September 2018 – August
2019 with possibility to extend
 Translation of national Product Information (PI) text for Novo Nordisk products the support
is asked for;
 Proofreading of national Product Information (PI) text translation for Novo Nordisk
products the support is asked for;
 Proofreading of abbreviated Product Information (aPI) adjusted based on the approved local
labelling;
 Proofreading of marketing promotional materials;
 Manuscript preparation for the Packaging Material Initiation (PMI) process;
 Proofreading of the manuscript prepared for the Packaging Material Initiation (PMI)
process;
 Initiation of PMI (Packaging Material Initiation) process in novoGloW based on which the
Printed Packaging Materials (PPMs: 8-no) are created according to local and company’s
requirements;
 Proofreading of the Printed Packaging Materials – PPMs (8-no) released in LOLA system
(Labelling Online Labelling Affiliates) against the text attached in the Packaging Material
Initiation (PMI) to ensure the illustrations and content are correct;
 To sign and date after each translation or proofreading, together with the other person
involved in the process, the following forms: Translation Checklist, Manuscript Checklist,
Translation and Packaging Material Creation Form;
 Proofreading of Directions For Use (DFU, equivalent as meaning with IFU - Instructions
For Use) translation for Clinical Trial Products as 2nd Affiliate Approver. After the final
translated text is delivered by the 1st Affiliate Approver to the CSC-DFU team, an email
mentioning that the Directions For Use (DFU) is available in PMX system will come
containing the Label Approval Request no (LAR). The Label Approval Request no (LAR)
will be sent to the 1st Affiliate Approver, to insert it in the Form for Affiliate Approval of
DFU. To check if the 1st Affiliate Approver signed the Form for Affiliate Approval of DFU
and only if yes, to do the proofreading and sign for approval (if no comments) in PMX
system;
 Proofreading of Clinical Trial labels translation for Clinical Trial Products as 2nd Affiliate
Approver. After the final translated text is delivered by the 1st Affiliate Approver to the
CSC-labels team, an email mentioning that the label is available in LOLA system will
come. Proofreading, signing for approval and submitting the label (if no comments) in
LOLA system are needed;
 LCR (Labelling Change Request) and CR (Change Request) case initiation in novoGloW, if
necessary (changes with impact on specifications of packaging materials, changes related to
production critical elements, changes to PPMs that differs from the NN design);
 Notify GLO (Global Labelling Operations-Part of RegOps) of regulatory revisions or new
regulation related to Printed Packaging Materials (PPM), if any;
 Coordination of batch delivery with local Product Supply in case of time critical Printed
Packaging Materials (PPM) updates, e.g. critical safety updates;
 Revision of RA PLANiT timelines (a global Regulatory Affairs planning system for the
planning of all files to be submitted to Health Authorities are represented by a RASP
containing detailed information on the submission);
 To handle and maintain registration status information in RIMS (Regulatory Information
Management System- is the IT system (database) used by NN to handle and maintain
registration status information on a country by country basis for all drug products and
medical devices, ensuring correct product release) in order to have the latest approved text
implemented on the market;
 Upload in NovoDOCS of national information corresponding to a MRP/DCP product;
 Upload in Grits-II system the corresponding RIMS Information Forms, when necessary;
 Maintaining updated the information from GlobeShare corresponding to Romania;
 Performing the activities related to Medical Devices, when necessary;
 Replying to emails when local information related to Regulatory Affairs information is
 required internally (by a Novo Nordisk employee);
 Preparation of the dossier for the approval/re-approval of Educational Material, when
support asked by Marketing;
 Preparation of the dossier for samples distribution approval, when support asked by
Marketingș;
 Offering consultancy, if needed.

o Regulatory Affairs Consultant for UCB Pharma Romania, SRL – January 2013 –
August 2017
 See regulatory and quality responsibilities listed below as employee of
UCB
 Responsibilities as back up LSO April 2014 – September 2016
 Other activities identified by UCB and agreed by the Consultant

o Regulatory Affairs Consultant for Alcon Pharma Romania SRL – November

2013 – December 2016
 Responsible for preparation of regulatory submissions to Romania and
Moldova Regulatory Authority (renewal, variations, translations)

 Maintains products database - up to date and fully compliant

 Other activities identified by ALCON and agreed by the Consultant

o Regulatory Affairs Manager at UCB Pharma Romania, SRL - March 2007 –

December 2012
 Responsible for preparation of regulatory submissions to Health
Regulatory Authority the registration files of UCB products, if necessary
modify and revalidate, and follow-up the validation process until the product
is registered.
 Develop & maintain regulatory knowledge of European regulations
 Negotiate and communicate effectively with regulatory authorities to
obtain timely product approvals
 Maintains product licenses and product databases are up to date and
fully compliant.
 Implementation of regulatory requirements according to corporate and
national rules
 Prepare the product labeling and organize implementation according to
corporate and national rules
 Link with the Product Quality Manager for timely implementation of
the approved labelling-associated artworks
 Review promotional material as part of LCC in line with available UCB
product information, local and global UCB SOP and with local rules and
regulation.
  Ensure the availability to the affiliate members and Global Regulatory
Affairs of all relevant regulatory data on new and existing UCB products and
data on new legislation changes
 Development of local SOPs, ensuring local training and compliance
 Responsibilities as back up QA (Ensure quality assessment of any
complaint received, Ensure that all authorized activities are in accordance
with GDP requirements, Assure that records are accurate and quality driven
in accordance with effective SOPs)
 Provide support for local inspections as defined by the Regulatory
Inspection Site Action Plan

o Regulatory Affairs Officer at GlaxoSmithKline SRL - March 2001 – February 2007

 To prepare and submit to NDA the registration files of GSK products, if
necessary modify and revalidate, and follow-up the validation process until the
product is registered.
 Maintains product licenses and product databases are up to date and fully
compliant.
 Preparation, review and approval of artworks
 Works collaboratively with Regulatory Affairs and Quality and with other
department colleagues to share best practice and information.
 Builds and maintains strong relationships with all personnel within NMA as
appropriate to ensure ease of access and influence.
 Supports EU regulatory initiatives and issues as appropriate.

o Chemist at National Drug Agency (1 year in the Control Department; 2 years in the
Evaluation Department) - April 1998 – March 2001
 Evaluation of chem/pharm documentation for the authorization or
reauthorisation of medicinal products for human use
 Quality control of medicines for human use

TRAININGS

o Preparing the Chemistry and Pharmacy Section of the EU Registration Dossier –

Common Technical Document requirements- Pharmaceutical Training International,
London
o "Think on your feet", Negotiation and Communication training – TMI, Bucharest
o Pharmaceutical Packaging, Labelling and Artwork – GSK, London
o Concentrated programme of Word'97 (advanced level) - ICL Millennium Training
Centre, Bucharest
o Concentrated programme of Access'97 (medium level) - ICL Millennium Training
Centre, Bucharest
 o RA Training for new Reg. Affairs Managers – UCB, Brussels
o Qualified Person Training – UCB, Turin
o Workshop SmPC/leaflet (readability of the target patient groups) – course organized
by the local Agency
o Mikado Training – Preparation of Regulatory submission using the Mikado EDMS –
UCB, Brussels
o Workshop QRD convention, version 8 – course organized by the local Agency
o U-PILOT training – UCB, Brussels
o GMPS training – UCB, Brussels
o TVT (Text Verification Tool) Training – Schlafender Hase, Brussels
o Patient Value Strategy Workshop - Bucharest

FOREIGN LANGUAGES

o ENGLISH

PC SKILLS
o MS OFFICE – very good knowledge and practice

ABILITIES

o Organizational and communication skills, team spirit, sociability

o Very organized, meticulous, tight to deadlines

REFERENCES

 Carina Manda – SE Immunology Med Head IT, RO, BG, GR - UCB Pharma

 Florentina Pancescu – Country Representative UCB Pharma Romania SRL