1. Hafiz Choudhury
Email: hafizur.choudhury@outlook.com Mobile: 07837867759
KEYEXPERTISE
Regulatory Affairs skills: More than 10 years of Regulatory Affairs experience in CTA, OTC
products, MAA, International submissions, Variation, Renewals and License Maintenance and MA
transfers
Geographic experience: Europe,Asia, Latin America, Middle East and Africa
Therapeutic experience: Allergy & Respiratory, Cardiovascular, Metabolic, Hepatology,
Inflammation, Neuroscience, Oncology, and Pain
Professional experiences
RegulatoryAffairs Manager (consultant), PAREXELInternational, Uxbridge, UK
May 2015 – present
Main responsibilities
 Primarily acting as a Parexel Project Lead (PPL) to manage, facilitate and coordinate the
delivery of submissions within a given project timelines
 Responsible for regulatory submissions throughout the product life cycle globally – EU,
North Africa (FSA), Asia, Gulf & LATAM by coordinating with local teams
 The planning, coordination and oversight of all processes involved in gaining approvals
required in each country for a projects.
 Liaising directly with Health Authorities and third party vendors to support regulatory
application
 Coordinate collection of functional documents in support of regulatory applications
 Involved in Project forecasting, activity and submission trackers
 Provide regulatory support to Commercial, Medical and Clinical departments through cross-
functional interactions in brand and therapeutic area teams
 Responsible for the preparation and maintenance of labelling to support MAAs and other
post-licensing activities. Ensures that any updates to the Product CCDS are implemented in a
timely manner. Liaises with affiliates and/or third parties to co-ordinate translational
activities and the subsequent submission of language versions to HA.
 Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that updates
to the product packaging components are implemented in line with approved labelling for
new MAAs or variations affecting the labeling, and in line with required timelines, for
products registered globally
 Liaises directly with local Affiliates, distributors or agents to define/clarify submission
requirements, and follow up on submissions, requests for supplementary information and
approvals with specific country and/or regional
Sanofi, Guildford, UK RegulatoryAffairs Manager (consultant)
August 2014 – April 2015
Main responsibilities
 Plan, participate and supervise the technical review and preparation of primary submissions
and variations to the MHRAand Ireland,

2.  Manage review and prepare,artwork changes for UK and Ireland i.e. in line with change of
ownership, site transfer
 Managed the review, preparation, submission and follow-up of regulatory submissions in the
UK,
 Managing the personal and professional development of colleagues within my team.
AMCo (Amdipharm Mercury Company Ltd) RegulatoryAffairs Manager (Consultant)
May 2012 –June 2014
Main responsibilities
 Management and preparation of rest of the world (ROW) technical and MAtransfers (non-
EU) + maintenance of established product licences.
 Review and preparation of the safety variations following critical findings from MHRA
inspections in UK,Ireland,
 Management and coordination of safety variation in EU and the rest of the world (ROW)
using affiliate’s and partners on establish products.
 Regulatory strategy, project manages regulatory submissions to agreed project targets.
 Provide operational regulatory input and guidance in cross-functional teams.
 Responsible for the preparation and maintenance of labelling to support MAAs and other
post-licensing activities. Ensures that any updates to the Product CCDS are implemented in a
timely manner. Liaises with affiliates and/or third parties to co-ordinate translational
activities and the subsequent submission of language versions to HA.
 Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that updates
to the product packaging components are implemented in line with approved labelling for
new MAAs or variations affecting the labeling, and in line with required timelines, for
products registered globally
 Liaises directly with local Affiliates, distributors or agents to define/clarify submission
requirements, and follow up on submissions, requests for supplementary information and
approvals with specific country and/or regional
Pfizer Ltd, Surrey, UK RegulatoryAffairs Manager (Consultant)
September 2011 – May 2012
Main responsibilities
Manage and Submit Marketing AuthorisationApplications:
 National/MRP/Decentralised- Review, co-ordinate and create necessary technicaldata to
support UK/Irish submissions e.g. provide national specific module 1 data (PIL, labelling) and
module 3
 Review and approve proposed regulated documents (SPC, PIL,and Labelling) and associated
artwork in line with regulations.
 Submit Periodic Safety Update Reports to MHRAand IMB.
 Submit MA RenewalApplications
PRAinternational (CRO), Reading, UK Senior RegulatoryAffairs Consultant
June 2011 - September 2011
Main responsibilities
 Review promotional materials for compliance with relevant national and EU legislation and
codes of practice
 Participate in project team meetings and sponsor teleconferences for initiation activity
(regulatory and ethics approvals) as well as maintenance activity in the EU, non-EU countries

3. in Europe
 Preparing CTAfor Regulatory authority in EU and non EU-countries
Sinclair Pharmaceuticals Ltd, Guildford, UK Senior RegulatoryAffairs Consultant
August 2010 - May 2011
Main responsibility
 Managing MA transfers in EU,Asia and Mina countries,
 Managing the maintenance of license this include renewal, Type IA,B and type II variations
 Gap analysis
 Advising on other development projects and prospective pre-clinical and clinical data,which
may form parts of new IMPD,CTA.
 Reviewing labelling and Patient Information leaflets to ensure compliance with current
legislation for it to be released in the market
 Corresponding with the National health agencies e.g. MHRA,Afssaps and FAMHP
Reckitt Benckiser Healthcare,Hull, UK
Jan 2010 - July 2010
Senior RegulatoryAffairs Consultant
Main responsibility:
 Managing the maintenance of OTC license this include renewal,Type IA, B and type II variations
 Switch application
 Corresponding with the National health agencies e.g. MHRAand Irish Medicines Board
 Reviewing labelling and Patient Information leaflets to ensure compliance with current legislation
for it to be released in the market
 Review of documentations from departments outside Regulatory Affairs i.e. marketing, medical,
PV,manufacturing, Quality Assurance,Labelling, Operations functions and R&D. Provides advice
with applicable Department Director consultation as to regulatory acceptability of plans for drug
development and marketing of the product
 Ensuring consistency of readability testing, liaising with external groups (package user-tests
vendors), as appropriate.
RegulatoryAffairs Manager (consultant), Wyeth, Maidenhead, UK
Aug 09 - Dec 09
Main responsibility:
 Managed regulatory aspects of projects/products, including applications (CTA, renewals,variation
etc) submitted to regulatory agencies.
 Developed effective proactive regulatory strategies for global product development, CMC,
labelling or promotional issues, and recommends such strategies to RATeam Leader,Team
Members and/or supervisor, as appropriate with minor oversight.
 Interfaced directly with governmental regulatory personnel, including scientific reviewers,
administrative staff and management, to facilitate the review and approval of regulatory
applications. Plans and facilitates formal meetings and teleconferences with regulatory authorities.
 Reviewed of documentations from departments outside Regulatory Affairs. Provides moderate adv
ice with applicable Department Director consultation as to regulatory acceptability of plans for dru
g development, CMC, labelling or advertising/promotion through individual as well as RA Team a
nd Interdepartmental Project Team contacts.

4. Cephalon, Welwyn Garden City, UK
July 08 - July 09
Regulatory Affairs Manager (consultant)
Main responsibility:
 Prepared Type I and Type II variation applications, Licence renewalapplications,
 Approval of UK, Ireland, and EU artworks, change of ownership applications and general
regulatory
requests to MHRA, IMB etc
 Prepare,update and implement labels and leaflets to ensure compliance with marketing
authorisations
 Worked closely with functional areas throughout the company. Advises functional areas regarding
content requirements for regulatory submissions. Critically reviews documents from functional con
tributors for consistency and completeness
MDS Pharma Services, Winnersh, UK
Jan 08 - July 08
RegulatoryAffairs Manager (Consultant)
Main responsibilities:
 Prepare the clinical trial applications to support exploratory and full development programs,
ensuring the documentation meets relevant regulatory requirements. Worked with Clinical teams
and advised them on appropriate regulatory strategy when co-coordinating multi-centre clinical
trials including countries like Korea,India, Poland and Brazil
 Review promotional materials for compliance with relevant national and EU legislation and codes
of practice
 Participate in project team meetings and sponsor teleconferences for initiation activity (regulatory a
nd ethics approvals) as well as maintenance activity in the EU, non-EU countries in Europe, South
Africa,Asia and Latin America.
Ipsen, Slough Regulatory Affairs Manager (Consultant)
July 07 - Dec 07
Main responsibilities:
 General regulatory affairs activities as requested. This included post licensing activities including
variations Type I and II's. The preparation of clinical trial applications and liaising with regulatory
agencies to ensure compliance with requirements and responding to queries.
 Managed the EU registration procedures in EU (Centralised or Mutual Recognition)
 Prepared and compiled various sections of the CTD with specific emphasis to non-clinical sections
of CTD.
 Reviewed and commented on protocols/briefing books and reports relating to preclinical, clinical
and CMC development.
 Worked closely with functional areas throughout the company. Advises functional areas regarding
content requirements for regulatory submissions. Critically reviews documents from functional con
tributors for consistency and completeness
Biogen Idec,Maidenhead/Slough
January 07 - June 2007
Regulatory Affairs Manager (consultant)
Main responsibilities:

5.  Prepared and/or reviewed and/or submission of marketing authorization Application documents for
EU and International Markets (Asia and Latin America)
 Worked on development strategy with project teams to develop regulatory strategy for assigned
projects.
 Liaised with Contract Research Organisations for initial Regulatory submissions and follow-ups on
queries and Amendments. Preparation and/or review of standard operating procedures etc
I3 Research, Maidenhead, UK
Oct 2005 - Dec 2006
Senior Regulatory Affairs Associate
Main responsibilities:
Co-ordinate Regulatory and ethics submissions
 Define a regulatory strategy for the clinical trials.
 Provide sponsor/PM with a list of all regulatory documents required to make submissions.
 Review and prepare regulatory documents for submissions
 Arrange translations of regulatory documents as required
 Prepare and make Regulatory and Ethics submissions in coordination of the project team as required.
 Track submissions and approvals activities and updates to the Project Teams and Sponsors.
 Make submissions of Amendments, IB updates, annual reports etc. as requested by the Sponsors and
PM.
 Provide PM/Sponsor with regular regulatory status updates as required
 Arrange payments of Ethics Committees and Regulatory Authorities
 Ensure that regulatory approvals remain in compliance with their authorisations and with
current regulatory requirements. This includes scrutinising and making recommendations on
all relevant documents e.g. Labelling, patient information leaflets and data sheets to ensure
conformance with appropriate current requirements.
Foster constructive and professional working relationships with all contacts – internal and external – s
o that applications are submitted and approved expeditiously.
Sanofi-Aventis UK Regulatory Affairs Specialist
January 2005 - Oct 2005
Main responsibilities:
Managed company name change by preparing and submitting updated artwork components to the PIU
(Product Information Unit) for UK, Ireland and International Markets
 Preparation and submission of IA/B variation applications
 Preparation and submission of Marketing Authorisation Renewals
 Corresponding with the National health agencies e.g. MHRAand Irish Medicines Board
 Reviewing labelling and Patient Information leaflets to ensure compliance with current legislation.
 Maintaining and updating regulatory databases
 Producing technical files for products
Regulator-e-AssociatesLtd,
April 2004 - Dec 2004
Regulatory Affairs Associate
Main responsibilities:
 Prepared CMC dossiers including compliance and technical variations.
 Reviewed current pharmaceutical journals for day to day relevance to the business.
 Handled regulatory activities for our European clients.
 Reviewed all current European legislation regarding Clinical Trials Directive and putting together det
ailed intelligence documents for training programmes for the company.

6. Other Experiences
Over five years experience working within multinational pharmaceutical companies and academic
research institutions. I have acquired a strong background in pre-clinical neuropharmacology and
physiology during which time I have developed a high level of expertise in both in-vivo and in-vitro
experimental techniques.
MRI Neurology CEDD, GSK, UK Research Scientist
 Preparation of different models of neural disease states.
 Testing compounds for Alzheimer's, pain and stroke disease.
 Collaborating with various groups, and presented data to internal and externalgroups
 Planning, designing and setting up experimental biology studies.
Merck Sharp and Dohme, UK Research Scientist
 Electro-physiology group to screen candidate drug compounds using patch clamp.
 Tested compounds for various groups including pain, anaesthesiology and stroke.
 Report writing, and presentation of data to different department within the company.
Schering-Plough, UK Research Scientist
 Produced live vaccines within a GMP quality control facility.
Royal Free hospital & UCLMedical School, London Research Scientist
 Investigation of the baroreceptor reflex in the Nucleus Tractus Salaturas (NTS) and looked at c-fos ex
pression
Training courses attended
 Basics of Regulatory Affairs 21 June 2004
 Basic Expedition LeadersAward (BELA) November 2002- November 2003
o Planning and preparation method
o Instructional and organizational
o Navigation
o Leadership and party management
o Conservation and access
o First aid and emergencies
 Variation to Marketing Authorisation (MHRAcourse),4 April 2005
Education
1995 - 1999 University of Portsmouth, U.K.
BSc (Hons) Pharmacology
1993 - 1995 South-Thames College, U.K
BTEC National Diploma in Science
Other skills

7.  Skills in using various Regulatory Databases i.e. Novas, GDMS, Pfleet,HATS, GRS
 Fluent in English & Bengali
References
Available on request.