Regulatory Affairs Professional - Pharmaceutical Sector
We are seeking a seasoned Regulatory Affairs professional to join our expanding team in the pharmaceutical sector.
As a key member of our regulatory team, you will play a crucial role in ensuring our diverse product portfolio complies with global regulatory frameworks.
Key Responsibilities:
* Ensure compliance with all relevant regulations and standards.
* Demonstrate knowledge and execution of Type IA, IB, and II Variations.
* 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 independently and take responsibility for your course of action.
What We Offer:
* A competitive salary, negotiable based on your experience.
* Performance-based bonuses to recognise your hard work and contributions.
* A hybrid working model, requiring you in our offices three days a week, with flexibility for remote work two days per week.
* Flexible start and finish times around our contracted hours to help avoid peak traffic.
* Significant opportunities for professional development and career advancement within the company.