Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Mona Mistry

Oxhey Hall,Hertfordshire

Summary

Astute Regulatory Affairs Consultant with 13 years of experience navigating complexities of legalisation and procedures.

Thorough and methodical individual maximises regulatory compliance through document management, open communication and legal advising.

Analytical legal professional with extensive knowledge of legislation relating to certificate requests for module 6 of the regulatory submissions package to Health Authority.

Driven individual eager to contribute strong communication and organizational skills. Proactively addresses challenges and meets stakeholder needs with minimal supervision. Ambitious planner and organizer with drive for professional and corporate success. Works collaboratively to align logistics with objectives. Strong deadline management and coordination skills.

Astute professional offers strong background in operations management. Possesses excellent interpersonal skills and high-level business acumen. Excels in detail-focused environments, leveraging industry knowledge and superior organisation skills.

Hardworking Regulatory Consultant brings proven success in overseeing administrative areas. Knowledgeable about best methods for managing resources, schedules and personnel to achieve objectives. Tech-savvy and always looking for improvement opportunities.

Diligent lead of the Regulatory Affairs team who works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

13
13

Years of Regulatory Experience

12
12

Years of Legal Experience

Work History

Regulatory Affairs Consultant

ICON Plc. (Formerly Takeda Development Centre UK)
Reading , West Berkshire
2014.03 - Current
  • Recommended measures to increase compliance to official legislation Of regulatory documentation for specific countries
  • Handling of official documents to maintain privacy, authenticity and accuracy.
  • Respond to time-sensitive queries quickly for fast resolution.
  • Advise stakeholders on aspects of legalisation of required regulatory documentation
  • Cross-matrix management of resources at global level
  • Observe official policies and procedures to be fully compliant internally and externally
  • Coordinate smooth regulatory signatures and legalisation requests with specific Marketing Authorisation Holders (MAH) within Takeda's company entities to ensure documentation are provided correctly, accurately to meet deadlines
  • Open communication channels with other officials to encourage productive dialogue.
  • Offer knowledge of legalisation and processes to guide decision-making.
  • Provided advice to gracefully handle and de-escalate conflict.
  • Investigate cases to reach resolution or conclusion.
  • Follow procedure to perform legal functions successfully.
  • Act as point of contact for uncertainties regarding handling of certificate requirement issues.
  • Partner with stakeholders to understand and define system requirements necessary to improve certificates request process and visibility
  • Assessed processes, procedures and work practices for strengths and weaknesses.
  • Facilitated system expansion, modification and updates.
  • Prepare proposals outlining requirements, potential solutions and required resources, timelines and costs to achieve objectives.
  • Design impressive solutions to overcome existing system challenges.
  • Identify current inefficiencies and recommended changing functionality or behaviors to eliminate concerns.
  • Outlined needs to meet end user requirements.
  • Consulted with users and management to tailor system to meet company needs
  • Onboarded and trained junior employees on company's procedures and processes for consistency and accuracy.
  • Foster positive team member relationships through communication, training and coaching.
  • Provide leadership and direction for team members, supervising activities to drive productivity and efficiency.
  • Mentor and equip certificate team members within certificate knowledge to improve service delivery in effective, accurate and timely manner
  • Influence business change and success through collaborations with different stakeholders
  • Process and approved invoice payments for all regulatory services requested by certificates team members using company systems through stakeholder systems
  • Liaise with management to gather and assess operational information.
  • Draft proposals to redefine functions and modify techniques.
  • Plan training schedules, prepared materials, reference guides, Visio Presentation for onboarding and mentoring of new employees/team members
  • Proactively cascading important information (changes and developments) to global team through communication tools and meetings
  • Draft & prepare documentation and packages for CoPP Applications to be submitted to Health Authorities (MHRA (UK) HPRA (Ireland) RP Tubignen (Germany) EMA (Netherlands) and FDA (USA)
  • Promoted continuous improvement by problem-solving and sharing suggestions to optimise team operations.
  • Developed appropriate resources and processes to meet needs and requirements of Stakeholder
  • Successfully delivered on tasks within tight deadlines.
  • Increased customer satisfaction by resolving issues.
  • Stayed current on processes and procedures to offer relevant assistance.
  • Applied critical thinking to analyse problems, evaluate solutions and select best decisions.

Stiefel Regulatory Operations Coordinator

Glaxosmithkline
Uxbridge , Hillingdon
2011.04 - 2015.06
  • Being direct report to Director of Global Regulatory Operations & Medicines Development
  • Acted as single point of contact for customers and internal stakeholders. Managed 30-40 emails
  • Built and nurtured professional relationships with wide range of stakeholders.
  • Project Manager/Project Coordinator for population of Stiefel Rx and OTC Products regulatory data within product registration (OPAL) database
  • Being super user and trainer for regulatory registration system (OPAL) for Stiefel Regulatory Team and Stiefel Community
  • Responsible for delegation and supervision of work to Stiefel team members
  • Engaged professionals in industry-specific knowledge, techniques and methodologies-in using registration system (OPAL) system
  • Produced training and supportive materials tailored to organisational needs.
  • Facilitated high-quality workshops, meetings and demonstrations online and offline.
  • Managements of group mailbox
  • Handled high volume calls to address customer inquiries and concerns.
  • Carried out day-to-day duties accurately and efficiently.

Document Manager & Archiving Coordinator

GlaxoSmithKline
Uxbridge , Hillingdon
2011.08 - 2014.06
  • Retrieval of documents, reports, dossiers from various in house or archiving facilities as and when required
  • Performed archiving of documentation on various in house systems (ECHO, SDA, PIER) daily
  • Processing and Issuing of D-numbers for all dossiers/data packages as and when requested by various Stiefel teams when required approximately 4-5 per week
  • Established and provided training and assistance on various archiving databases/system (Daily)
  • Proactively assisting with locating legacy Stiefel studies/reports/records for Medical Affairs and Consumer Stiefel Departments from Archive and storage systems and facilities (1-2 enquiries per week)
  • Supported team by demonstrating respect and willingness to help.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Completed duties to deliver on targets with accuracy and efficiency.
  • Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.

Product Registration Database (OPAL) Administrator

GlaxoSmithKline
Uxbridge , Hillingdon
2010.01 - 2011.01
  • Established and maintained effective communication and networks with Global Local Operating Companies to gain product information to populate Product Registration System (OPAL) with product portfolio
  • Creation and maintenance of GSK UCB drug portfolio product lifecycle information within OPAL database (76 Products within 50 Countries)
  • Management of OPAL mailbox ( 30-50 e-mail enquiries per day approx.)
  • Establishing relationships with various teams within GSK to ensure product data is obtained for populating database

Treasury/Legal Conveyancing Assistant

Thames Valley Housing Association
Twickenham , Richmond upon Thames
2003.01 - 2003.06

Residential Conveyancer

Burt Brill & Cardens
Brighton , Brighton and Hove
2001.01 - 2002.01

Conveyancing Paralegal

Athi Kurdistan Smith Solicitors
West Bromwich , Sandwell
1997.01 - 2001.10

Education

Post Graduate Diploma - Legal Practice

University of Central England in Birmingham
Birmingham
01.2001

Bachelors of Law LLB (Hons) - Law

University of Central England in Birmingham
Birmingham
01.1999

Skills

  • Attention to Detail
  • Works with High level of Accuracy
  • Team Leader
  • Process orientated
  • Customer Focused and driven
  • Project Management skills
  • Highly organised
  • Excellent Communicator
  • Tact & Diplomacy
  • Effective Time Management
  • Attention to Detail
  • People person who strives in Relationship building
  • Liaising with Regulatory Agency and highly specialised in Certificates of Pharmaceutical Products (CoPP's) Application drafting and applying (FDA, German HA, Belgium Health Authority, European Medicines Agency)
  • International Regulations awareness and compliance knowledge
  • Regulatory knowledge

Languages

English
Native
Gujarati
Fluent

Timeline

Regulatory Affairs Consultant

ICON Plc. (Formerly Takeda Development Centre UK)
2014.03 - Current

Document Manager & Archiving Coordinator

GlaxoSmithKline
2011.08 - 2014.06

Stiefel Regulatory Operations Coordinator

Glaxosmithkline
2011.04 - 2015.06

Product Registration Database (OPAL) Administrator

GlaxoSmithKline
2010.01 - 2011.01

Treasury/Legal Conveyancing Assistant

Thames Valley Housing Association
2003.01 - 2003.06

Residential Conveyancer

Burt Brill & Cardens
2001.01 - 2002.01

Conveyancing Paralegal

Athi Kurdistan Smith Solicitors
1997.01 - 2001.10

Post Graduate Diploma - Legal Practice

University of Central England in Birmingham

Bachelors of Law LLB (Hons) - Law

University of Central England in Birmingham
Mona Mistry