Regulatory Affairs Specialist - Pharmaceutical Industry
We are seeking an experienced Regulatory Affairs Specialist to join our team in the pharmaceutical industry. As a key member of our regulatory team, you will play a critical role in ensuring our products comply with global regulatory frameworks.
Key Responsibilities:
* Ensure product compliance with relevant regulations and standards.
* Demonstrate knowledge and execution of IA, IB, and II Variations.
* Manage licence transfers in various international territories.
* Review promotional material for medicinal products.
* Prepare Module 1 documentation for National Applications.
* Participate in meetings with Regulatory Authorities.
* Deal with regulatory aspects of internationalising products and applying for reclassification.
* Train and mentor junior team members on Regulatory processes and compliance requirements.
* Monitor and interpret regulatory trends and changes relevant to the industry.
Requirements:
* 3-4 years of progressive experience in Regulatory Affairs within the pharmaceutical industry (human health).
* Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries.
* Exceptional attention to detail and outstanding organisational skills.
* Capability to work on your own initiative and take responsibility for your course of action.
Benefits:
* Competitive salary negotiable based on experience.
* Performance-based bonuses.
* Hybrid working model allowing flexibility between office and remote work.
* Flexible start and finish times to avoid peak traffic.
* Ongoing career development opportunities within a rapidly expanding company.