Senior Regulatory Affairs Specialist Jobs in Pharmaceutical Industry
Job Description: Regulatory Affairs Expertise
We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have extensive knowledge of regulatory frameworks, pharmaceutical products, and submission processes.
Key Responsibilities:
* Ensure compliance with global regulatory requirements for diverse product portfolios.
* Develop and implement Type IA, IB, and II Variations strategies.
* 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.
* Oversee the regulatory aspects of internationalising products and applying for reclassification.
* Mentor junior team members on Regulatory processes and compliance requirements.
* Monitor and interpret regulatory trends and changes relevant to the industry.
Required Skills and Qualifications:
A resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs.
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.
Ability to work independently and take responsibility for your course of action.
What We Offer:
A highly competitive salary, negotiable based on your experience.
Performance-based bonuses to recognise your hard work and contributions.
Hybrid working model, requiring you in our offices near Dunboyne, Co. Meath three days a week, with flexibility for remote work two days per week.
Career progression opportunities within a growing company with ambitious plans.