Regulatory Affairs Specialist (CORE)

Owned by Bart De Pelsmaeker (Unlicensed)
Last updated: Mar 07, 2024
2 min read

This would include the Job Title “Regulatory Change Specialist”

 

Persona: Regulatory Affairs Specialist

 

Name: Ayesha Khan

Age: 36

Education: Master's degree in Regulatory Affairs, Bachelor's in Biochemistry.

Professional Background:

  • Over ten years of experience in the pharmaceutical industry, specializing in regulatory affairs.

  • Previous roles included Quality Control Analyst and Regulatory Affairs Coordinator.

  • In-depth knowledge of FDA, EMA regulations, and international pharmaceutical compliance standards.

Industry: Pharmaceutical

Responsibilities:

  • Keep abreast of international legislation, guidelines, and customer practices in pharmaceuticals.

  • Compile, prepare, and manage regulatory submissions and registrations.

  • Liaise with regulatory authorities and ensure that products comply with regulatory requirements.

  • Provide strategic advice to senior management on regulatory risks and strategies.

  • Coordinate with various departments to ensure all products comply with regulatory standards.

Goals:

  • To ensure that all products meet stringent regulatory standards and achieve market approval.

  • To maintain compliance with all regulatory requirements across different markets.

Challenges:

  • Navigating complex and varied international regulatory landscapes.

  • Keeping up-to-date with constantly evolving regulations and guidelines in the pharmaceutical industry.

  • Ensuring efficient and timely regulatory submission processes.

Motivations:

  • A solid commitment to ensuring public health and safety through rigorous regulatory compliance.

  • A passion for bridging the gap between scientific innovation and regulatory policies.

Tech-Savviness:

  • Proficient in regulatory submission software like Veeva, MasterControl

  • Familiar with regulatory databases and compliance management systems.

Behavioral Traits:

  • Meticulous attention to detail and strong organizational skills.

  • Excellent communication skills for liaising with regulatory authorities and internal collaboration.

  • Analytical and strategic thinking, with an ability to anticipate regulatory trends and challenges.

 

Quote: "In regulatory affairs, our role is to be the bridge between groundbreaking science and the patients who need them, ensuring safety and compliance at every step."