Maryam Tahoor
London,United Kingdom
Summary
Regulatory Affairs Manager skilled in navigating complex regulatory landscapes and ensuring compliance across multiple regions. Demonstrated success in managing submissions, providing strategic guidance on product labeling, and conducting training sessions to enhance internal understanding of regulatory requirements, fostering collaboration and efficiency.
Overview
2
2
Languages
1
1
Certification
21
21
years of professional experience
Work History
Regulatory Affairs Manager
ELIQUENT Life Sciences, Inc
09.2021 - Current
- Managed interactions with regulatory agencies during product approvals.
- Conducted training sessions on regulatory requirements for internal staff.
- Coordinated cross-functional teams to ensure compliance with regulations.
- Evaluated changes to documents submitted to determine need for amendments.
- Updated in-depth trackers of approvals and submissions.
- Gathered and analyzed scientific data to formulate explanations and arguments for regulatory authorities.
- Submitted applications and amendments to regulatory agencies.
- Collaborated with cross-functional teams to interpret and communicate new and revised laws.
- Managed the submission process of new products or changes to existing products through the appropriate national health authorities.
- Prepared documents for submission to regulatory authorities in accordance with applicable laws and regulations.
Teacher
Northwood School
01.2018 - 01.2021
- Started as a volunteer; due to my focus and commitment the management hired me as a year group teacher.
- Lesson planning and taking initiatives to keep the students and team engaged.
- Voluntarily teaching language within the local community to people with English as a second language
Sales Assistant
Hammersmith Hotels Ltd
01.2015 - 01.2019
- Develop marketing strategies and online sales in conjunction with management to increase revenue
- Managed Sales accounts; creating and maintaining relationships with clients.
Private Tutor
01.2007 - 01.2012
- Taught children aged 4-8 yrs Maths and Science.
- Responsible for tutoring students in a private, nonclassroom setting; either individually or in small groups (6 max.)
- Helped improve study skills, note-taking, and test-taking strategies, grasping challenging content, working on individualised plans.
ANI International
01.2009 - 12.2009
- Responsible for developing a syllabus/ course for a summer camp, which was used at multiple sites for over 100 children and led the head of ANI to recognize my leadership, enthusiastic instruction and “above-and-beyond” commitment shown to helping maximize learning outcomes and student success.
- Coordinating the content development with teachers and management at ANI, ensuring alignment was reached before execution of the program
- Project lead for one of the camps that held 15 children for the duration of the program
- Lead administrator across sites to collate notes and help assess adjustments required to further enhance the program
- Worked with each site lead and teachers to prepare end of camp reports for parent(s)/ guardian(s)
- Non-Profit Charity Organization
Vice President of Science Welfare Society
Punjab University
01.2006 - 01.2009
- Responsible for organising the team and keeping them motivated.
- Organising charity events to raise funding for underprivileged students.
- Spreading awareness within the local community by setting up talks on the importance of science.
Education
B.Sc. (Hons) - Physics
University of the Punjab
Pakistan01-2009
Alevels - MATHS, PHYSICS, ENGLISH & URDU
The Lahore Alma
Pakistan01-2004
Metric - CHEMISTRY, BIOLOGY, PHYSICS, MATHEMATICS, ENGLISH, URDU, SOCIAL STUDIES
Defense Public School
PakistanSkills
- WARM & FRIENDLY ENGAGING PERSONALITY
- HIGHLY PRESENTABLE
- SOCIABLE
- STRONG COMMUNICATOR
- UNDERSTAND CLIENT NEEDS
- STRONG COLLABORATION SKILLS
- IT LITERACY
- MICROSOFT WORD
- MICROSOFT EXCEL
- MICROSOFT POWERPOINT
- Document management
- Training development
- Cross-functional collaboration
- Project management
- Market access strategy
- Effective communication
- Problem solving
- Attention to detail
- Leadership skills
- Product lifecycle management
- Time management
- Relationship building
- Strategic planning
- Multitasking
Accomplishments
- Green Belt Certification holder for Medical Devices
- Experience with NTA-to-CTD conversion projects for legacy medicinal products, ensuring compliance with current regulatory requirements.
- QMS compliance with ISO 13485 and MDR 2017/745
- Marketing Authorisation Applications, lifecycle management activities and post-approval regulatory submissions for oncology products across global markets.
- Quality Control and regulatory review of high-value submission documents including briefing books, Orphan Drug Designation applications, Scientific Advice procedures and other regulatory dossiers.
- Experience in regulatory strategy and geo-expansion support for product registrations across Rest of World (ROW) markets.
- Extensive experience using Veeva Vault and other electronic document management systems to support global regulatory submissions, document control and lifecycle management activities.
Personal Information
Title: Regulatory Affairs Manager
Languages
English
Professional
Urdu
Professional
Certification
- Green Belt Certification for Medical Devices
Timeline
Regulatory Affairs Manager
ELIQUENT Life Sciences, Inc
09.2021 - Current
Teacher
Northwood School
01.2018 - 01.2021
Sales Assistant
Hammersmith Hotels Ltd
01.2015 - 01.2019
ANI International
01.2009 - 12.2009
Private Tutor
01.2007 - 01.2012
Vice President of Science Welfare Society
Punjab University
01.2006 - 01.2009
B.Sc. (Hons) - Physics
University of the Punjab
Alevels - MATHS, PHYSICS, ENGLISH & URDU
The Lahore Alma
Metric - CHEMISTRY, BIOLOGY, PHYSICS, MATHEMATICS, ENGLISH, URDU, SOCIAL STUDIES
Defense Public School