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Regulatory Affairs Specialist with over 10 years of experience in pharmaceuticals, medical nutrition, and cosmetics. Expertise in global product registration, regulatory compliance, and cross-functional coordination with health authorities, distributors, and manufacturers. Strong knowledge of international regulatory requirements, including ingredients, labeling, product claims, and documentation processes.

Solution-oriented and problem solver with 7 years in regulatory of medical device and pharmaceutical fields. Highly skilled in communication, collaboration, regulatory system, and technical documentation. Proficient in current pharmaceutical and medical device regulations, standards, and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.

Accomplished regulatory compliance specialist with extensive expertise in pharmaceutical and medical device regulations. Demonstrates proficiency in strategic partnership development, regulatory submissions, and documentation management, ensuring adherence to ICH guidelines and pharmacovigilance standards. Known for exceptional analytical thinking and problem-solving abilities, coupled with effective communication skills that facilitate conflict resolution and team coaching. Committed to advancing regulatory knowledge and compliance reporting within Azerbaijan's regulatory regimes, aiming to enhance benefit-risk determination processes.
Loyal employee with solid understanding of training and mentoring employees. Dedicated team player, proactive and hands-on in task completion.
Takes on challenging new role harnessing interpersonal skills, collaboration and problem-solving. Driven to deliver high-quality service and consistent results.
Regulatory professional with focus on compliance and risk management in highly regulated industries. Facilitate product approvals and maintain compliance through thorough knowledge of regulatory frameworks and strategic documentation. Drive successful submissions and minimise delays by liaising with regulatory bodies and cross-functional teams.

Detailed-oriented and result-driven Regulatory Affairs Specialist with over 5 years of experience in the medical device industry specializing in regulatory submissions and auditing quality management system(QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, EU Medical Device Regulation (MDR), and ISO 14971, ensuring organizations meet regulatory requirements and maintain high-quality standard An in depth knowledge in risk assessment, root cause analysis, and developing corrective and preventive actions (CAPA). Strong analytical skills, attention to detail, and a commitment to continuous improvement.
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Possesses versatile skills in project management, problem-solving, and collaboration. Brings fresh perspective and strong commitment to quality and success. Recognized for adaptability and proactive approach in delivering effective solutions.

Driven Regulatory Affairs Specialist with knack for navigating complex regulatory landscapes and ensuring compliance. Excelled in streamlining approval processes, reducing time-to-market for products and maintaining up-to-date knowledge of evolving regulations. Known for fostering collaborative relationships with cross-functional teams to achieve seamless regulatory submissions and approvals.

Thelma Gore

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Overview

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Regulatory Affairs Specialist

Research & Regulatory Affairs Supervisor

Research & Regulatory Affairs Associate

Pharmacy Technician & Administration

Graduate Research Student

Education

Master of Science - Industrial Pharmaceutics

Bachelor of Science - Biological Sciences with Biomedicine

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Certification

Regulations

Community Service

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Regulatory Affairs Specialist

Research & Regulatory Affairs Supervisor

Research & Regulatory Affairs Associate

Pharmacy Technician & Administration

Graduate Research Student

Master of Science - Industrial Pharmaceutics

Bachelor of Science - Biological Sciences with Biomedicine

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