Regulatory Affairs Professional
Key Responsibilities:
* Maintain regulatory compliance for products in various territories.
* Implement Type IA, IB, and II Variations effectively.
* Manage licence transfers across international markets.
* Review promotional material for medicinal products to ensure accuracy.
* Prepare Module 1 documentation for National Applications.
* Participate in meetings with Regulatory Authorities to discuss product approvals.
* Handle regulatory aspects of internationalising products and applying for reclassification.
* Train junior team members on Regulatory processes and compliance requirements.
* Monitor and interpret regulatory trends relevant to the industry.
Requirements:
* Minimum 3-4 years progressive experience in Regulatory Affairs within the pharmaceutical industry (human health).
* Demonstrable experience with preparing and submitting dossiers for multiple EU countries.
* Exceptional attention to detail and outstanding organisational skills are essential.
* Able to work independently and take responsibility for actions.
Responsibilities Include:
Ensuring regulatory compliance, managing licence transfers, reviewing promotional material, and participating in meetings with Regulatory Authorities.
What We Offer:
A challenging role with opportunities for growth and development, as well as a competitive compensation package.
Benefits:
Opportunities for professional growth and development, competitive compensation, and a dynamic work environment.
Other Information:
This role is ideal for a motivated and experienced Regulatory Affairs professional looking to take their career to the next level.