TOTAL EXPERIENCE: Mrs. ASWATHY SUSAN JOHN, M.

PHARM
PHARMACIST/ REGULATORY AFFAIRS MANAGER/
SCIENTIST-R&D-QA & PRODUCT DEVELOPMENT SUPPORT
UAE PH:00971-558619632 email:[email protected]

EXPERTISE EXPERIENCE
Regulatory Affairs, R&D-QA, Product OCTOBER 2023-PRESENT
Development Support, Documentation of REGULATORY OFFICER ,At NUTRIPHARM FZC,DUBAI
Pharmaceuticals, Personal Care Cosmetics, Food, Personal Care Cosmetics, Health Supplements
Medical Devices, Health Supplements, Food Consumer product Registration (CPRE), Food Registration (FIRS),Consumer product Import Permit
application (CPIP)
ARENAS HANDLED:
APRIL 2021 – APRIL 2022
 Direct: MOHAP, DM – MONTAJI & IRS, SFDA-
REGULATORY AFFAIRS MANAGER, At The Principals MENA DMCC, DUBAI
FRCS & e-COSMA, ESMA – MOIAT
Pharmaceuticals, Food, Personal Care Cosmetics, Health Supplements, Baby Care articles & Medical
 Through Consultants & Local agents: ESMA- Devices.
MOIAT, SABER, MOH KUWAIT, QATAR, BAHRAIN,
 Responsible for managing Regulatory Affairs Department in the organization and RAQA Compliance
OMAN, PHILIPPINES, ALL GCC, MENA REGIONS
 Registration application and Submission with MOHAP, DM Montaji, Food - IRS, e-COSMA, FRCS, ESMA.
CASE PROFICIENCIES  Conducting on call meetings with client’s and supplier’s, regulatory teams
REGULATORY AFFAIRS  Coordinating with certification bodies for ESMA, SABER Certificate of Conformities.
 Regulatory Compliance and Submissions  Coordination with Regulatory Authorities, Regulatory response management, local agent management
(Registration, Renewal, Minor Variations, Site and Client management
Registration, Artwork Registrations in respective  Documentation : Preparation, Review, Compilation of CTDs/e-CTDs, Module 1,2,3 (CMC -Quality Part)
authorities) & 5, CSTD,STED, ACTD, Technical Files, MOHAP & DM Registration Dossiers , Artwork /Labels, Review
 RA Documentations – Preparation of e- of Design Dossiers, ESMA & MOIAT documents.
CTDs/CTDs (Modules -1,2,3(CMC-Quality part) &  Responsible for subordinate’s activities, allotting day to day tasks, approval of leaves, Review and
5), CSTDs, STEDs, DMFs (Device Master Files), responses to higher management.
Technical files, ACTDs, Registrations, Renewal,  Study and get budget approvals on approved projects from management
Minor variation, Site/Vendor registration MARCH 2019 – MARCH 2021
Dossiers, COCs, PILs, Review of Design files, Audit RAQA OFFICER, At ALICT FZC LLC, AJMAN
reports, PIFs, CPSRs, BABE Reviews, Artworks,  Para Pharmaceuticals, Personal Care, Baby care Products & Toys
BMRs, BPRs  Regulatory & Quality Compliance, Documentation and Submissions With DM & Coordination with
R&D QA & PRODUCT DEVELOPMENT Notified Bodies for ESMA & SABER
SUPPORT  MARCH 2015 – MAY 2018
SCIENTIST, At HIMALAYA GLOBAL RESEARCH CENTRE, DUBAI
 Product Development Support – Stability Personal Care & Pharmaceutical Products’ Regulatory, Quality & Product Development Support
Studies, Preformulation Studies, Excipient  Meticulously ensured Regulatory and Quality Compliance during development and handled
Compatibility Studies preparation, collection, compilation and control of all regulatory and quality documents required for
R&D Quality Management- IPQC during registration of new products (for MENA, EU, UAE)
Development, Compliance and Document  Carried out various Product Developmental Studies such as Preformulation Studies, Excipient
Control, SOPs & Trainings Compatibility Studies, IPQC checks during development
 QA Documentations - Specifications, CoAs,  Developed & implemented around 80 SOPs for various departments and trained all stakeholders on
MSDS, PDRs, MFRs, Validation Protocols, Risk the successful implementation of the same.
Management Plan and Reports  Executed the Stability Studies of around 30 Personal Care & Pharmaceutical Products
FEBRUARY 2012 – FEBRUARY 2015
ADMINISTRATIVE & DEPARTMENT
REGULATORY AFFAIRS EXECUTIVE, At NEOPHARMA LLC, ABUDHABI
MANAGEMENT Pharmaceuticals – Generic , GSL
Team Management, PMFU/ Query Management,
 Registrations and Renewals, Minor Change Approvals, Site Registrations, Handling PMFU Queries
Regulatory response management, Local agent
 Preparation and submission of Dossiers & CTDs – MODULE 1, 2, 3, (CMC-Quality part) & 5, for GCC
management, Client management, Budget
(includes SFDA, MOHAP, UAE), CIS & MENA markets
Approval, Daily task allotment & Assessment,
 NOVEMBER 2008–AUGUST 2009
Leave approvals
TRAINEE PRODUCTION CHEMIST At SANGROSE LABORATORIES PVT.LTD, INDIA
CERTIFICATIONS  Pharmaceuticals & Personal Care Products
 JUNE 2018  Production & Packaging Supervision, IPQA of Tablets, Syrups, Capsules, Creams & Ointments
Level 4 Award in Food Safety Management EDUCATION
From Highfield Awarding Body for Compliance
HABC, UK with lifetime validity 2009 – 2011 MASTER OF PHARMACY, M. Pharm, (Pharmaceutics) – Vels University, Vels Institute
of Science, Technology & Advanced Studies, Tamil Nadu, India with CGPA – 7.01, OWAM - 79.38,
 FEBRUARY 2016 - JULY 2016
Average % Of Marks- 78.57 %.
Industry Certification in Pharmaceutical Quality
2004 – 2008 BACHELOR OF PHARMACY, B. PHARM
Assurance and Quality Control (Quality Council
of India (QCI) Government of India Approved & Rajiv Gandhi University of Health Sciences, JSS College of Pharmacy, Karnataka, India With
Certified) from IGMPI, New Delhi, India Average % Of Marks - 73.5%
MAIN JOB RESPONSIBILITIES HANDLED
I. Regulatory Affairs

 Manage Regulatory Affairs Department in the organization.

 Coordination with Regulatory Authorities, Query Response Management, Compliance,
Regulatory response management, Documentation, Dossier Review and local agent
management, Client management .
 Identify compliance requirements for products at the national and regional levels and
ensures the same during New products Development and for the Registration, Renewal and
Minor Variations in various countries as per the regulations laid down by the regulatory
bodies of respective countries (mainly UAE, GCC, CIS, MENA ).
 Registration application and Submission with MOHAP, DM Montaji, Food - IRS, e-COSMA,
FRCS, ESMA.
 Coordinating with certification bodies for ESMA, SABER Certificate of Conformities.
 Preparation, review, compilation and submission of CTDs/e-CTDs, PIFs, CPSRs, Tech
files/Design Dossiers & other dossiers for the registration, renewals, minor variations,
vendor/manufacturer site registrations , conformity certifications for Pharmaceuticals, OTCs,
Herbal, Food, Health Supplements, Personal Care Cosmetics, Medical Devices , Baby Care &
Feeding articles, Toys & Animal Health products with international regulatory agencies as
per the regulations and guidelines of respective country (UAE, KSA, other GCC, CIS, MENA )
 Monitor and identify pending regulatory changes and make recommendations for ensuring
ongoing compliance with new regulations.
 Studies and reviews Bioavailability and Bioequivalence files (BABE), Claim substantiation
reports and other efficacy and safety study reports so as to incorporate the information into
CTDs, PIFs and CPSRs.
 Support organizational growth by collaborating with cross functional teams to identify global
regulatory requirements, maintain registrations and register products in new markets.
 Reviewing art works and specifying storage, labeling and packaging requirements.
 Managements of MOH queries and PMFUs.
 Preparation and revision of leaflets for new and existing products.
 Keep track of product lifecycle and pre prepare for all major actions so as to prevent
hindrance in business.
 Follow up with regional and international agents regarding pending issues.
 Update and maintain Information systems related to regulatory.
 Compile the manufacturing and quality Control parts of regulatory submissions made locally
and regionally.
 Assist the Line manager in handling regulatory requirements related to the manufacturing
needed for marketing applications.

II.Product Development Support, Stability Testing & Production

 Assist Principle Scientist in Product Development by carrying out various Product

Developmental Studies such as Preformulation Studies, Excipient Compatibility Studies, IPQC
checks during development.
 Collaborate with Product Development to proactively identify compliance risks during
product conceptualization; develop regulatory strategies to ensure compliance throughout
the product development and lifecycle.
 Review ingredient lists for regulatory compliance across multiple jurisdictions, provide sign-
off on final formulation from a regulatory perspective.
 Research and review literatures and articles from journals and related sites to study the
expertise of similar processes carried out. Also maintain and archive the same.
  Prepare ingredient lists for all new and reformulated products using INCI Nomenclature.
 Review and sign-off on product labels and promotional materials, including for compliance
with applicable standards and regulations.
 Management including planning, coordination and execution of product testing for stability,
preservative efficacy, and microbiological studies as per protocol, track testing dates and
ensure completion in time for launch.
 Responsible for collection, review, verification, reporting any OOS noticed & compilation of
all the above study reports along with Claim substantiation and Bioequivalence (BABE)
studies as available.
 Production & Packaging Supervision, IPQA of Oral & Topical dosage forms such as Tablets,
Syrups, Capsules, Creams & Ointments
III. Quality Management, Documentations, SOPs & Training

 Performs Quality oversight of the R&D departments as well as the assigned contract
manufacturing /testing partners, vendors for GLP or GMP compliance as demanded.
 Supports internal audits plan by executing self and following-up on action plans for GLP
Compliances.
 Reports deviations from quality standards and intiate and facilitate change controls including
CAPA documentations.
 Makes recommendations for SOP revisions for the Quality Operations and gets approval from
the stakeholders and management on the same.
 Preparations, issuance, control, retrieval and implementation of all SOPs and conduct
trainings to the employees on the same.
 Management of all Quality documents including preparation, review, analysis, revision,
issuance, distribution, retrieval and archival of Specifications, Standard (Analytical) Test
Procedures, Certificate of Analysis (CoAs), MSDS (Material Safety Data Sheet), BMRs, BPRs,
PDRs, MFRs, Composition Certificates (COCs) as per GDP.
 Collaborate with vendors, including formulation and manufacturing partners, to ensure
complete and accurate documentation of formulas, manufacturing records and raw material
information.
 Reviews and analyses all product documents and assist in validating the vendors based on
the specification checklists.
 Create and maintain allergen lists for all new and existing products.
 Develop and implement document management processes to ensure proper storage and
access to information.
 Evaluate and recommend improvements to existing processes.

PARTICULARS
 Date of Birth – 03 /01/1986
 Languages Known – English, Hindi, Malayalam
 Valid Driving Licenses – UAE, India
 Sponsorship - Husband
REFERENCES
On Request