Summary
Overview
Work history
Education
Skills
Sprachkenntnisse
Timeline
Generic
Khanim Akbarli

Khanim Akbarli

Baku,Aserbaidschan

Summary

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.

Overview

7
7
years of professional experience
6
6
years of post-secondary education

Work history

Regulatory affairs specialist

Vefa İlaç San ve Tic A.Ş.
Baku
10.2023 - Current
  • Streamlined product labelling process, ensuring consistency across all products.
  • Collaborated closely with scientific teams, enhancing understanding of complex technical issues.
  • Reviewed promotional materials, ensuing adherence to regulatory guidelines.
  • Provided training sessions on current regulations and guidance documents.
  • Prepared detailed responses for queries from regulatory agencies, facilitating prompt resolutions.

Business development manager

EGA GRUP LLC
Baku
09.2021 - Current
  • Unveiled new revenue streams through diversification strategies.
  • Optimised operational procedures for improved productivity.
  • Led cross-functional teams to deliver complex projects on time and budget.
  • Handled crisis situations effectively, minimising impact on business operations.
  • Developed strategic partnerships for sustained growth.

Regulatory affairs manager

Azerimed CJSC
Baku
11.2018 - 10.2023
  • Maintained up-to-date knowledge on relevant legislation, ensuring business operations remained compliant at all times.
  • Proactively identified potential risks, thus reducing instances of non-compliance.
  • Assisted in policy formulation, leading to a more robust regulatory framework within the organisation.
  • Liaised with health authorities for successful product registrations.

Pharmacist

Zeytun Aptek Ag Sheher
Baku
04.2018 - 10.2018
  • Kept accurate records of all dispensed items, adhering strictly to legal requirements.
  • Assisted in training junior staff members, contributing to an efficient work environment.
  • Participated in public health campaigns within the local community; promoted healthy lifestyle choices.
  • Minimised errors in prescription handling through meticulous attention to detail.

Education

bachelor - Pharmacy

Azerbaijan Medical University
Baku
09.2014 - 09.2018

master degree - İndustrial Pharmacy

Baku branch of the 1st Moscow State Medical University named
Baku, Baku City
09.2020 - 06.2022

Skills

  • Regulatory compliance
  • Team coaching
  • Conflict resolution
  • Problem solving
  • Attention to detail
  • Strategic partnership development
  • Regulatory submissions
  • Medical device regulation familiarity
  • Effective communication
  • Regulatory documentation mastery
  • Knowledge of ich guidelines
  • Benefit-Risk determination
  • Analytical thinking strength
  • Technical dossier preparation
  • Reporting mechanism expertise
  • Pharmaceutical industry regulations familiarity
  • Pharmacovigilance regulations proficiency
  • Regulatory compliance knowledge
  • Documentation management
  • Azerbaijan regulatory regimes
  • Compliance reporting
  • Excellent written skills
  • Regulatory knowledge

Sprachkenntnisse

Deutsch: Keine Kenntnisse, Grundkenntnisse, Erweiterte Kenntnisse, Verhandlungssicher, Muttersprache
Intermediate
Englisch: Keine Kenntnisse, Grundkenntnisse, Erweiterte Kenntnisse, Verhandlungssicher, Muttersprache
Upper intermediate
Russian
Native
Turkish
Fluent

Timeline

Regulatory affairs specialist

Vefa İlaç San ve Tic A.Ş.
10.2023 - Current

Business development manager

EGA GRUP LLC
09.2021 - Current

master degree - İndustrial Pharmacy

Baku branch of the 1st Moscow State Medical University named
09.2020 - 06.2022

Regulatory affairs manager

Azerimed CJSC
11.2018 - 10.2023

Pharmacist

Zeytun Aptek Ag Sheher
04.2018 - 10.2018

bachelor - Pharmacy

Azerbaijan Medical University
09.2014 - 09.2018
Khanim Akbarli