Senior Regulatory Affairs Specialist - Pharma
Senior Regulatory Affairs Specialist - Pharma
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Senior Consultant, Sciences & Healthcare Recruitment @Amicus
Senior Regulatory Affairs Officer – Pharmaceuticals (Hybrid)
Location: Offices based near Clonee, Co. Meath, Ireland
Our client, a thriving Irish pharmaceutical group, is experiencing significant growth with market-leading OTC and Prescription medicines across numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experienced Senior Regulatory Affairs Officer to join their growing team. This new position reports into the Regulatory Affairs Manager and offers a fantastic opportunity to make a tangible impact within a dynamic, family-run business that prioritises performance and offers excellent career progression.
What You'll Do:
As a Senior Regulatory Affairs Officer, you'll play a crucial role in ensuring the company's diverse product portfolio complies with global regulatory frameworks. This is a hands-on role where you'll be expected to get stuck in and drive results. Your key responsibilities will include:
* Ensuring the company’s products comply with all relevant regulations and standards.
* Demonstrating knowledge and execution of Type IA, IB, and II Variations.
* Managing licence transfers in various international territories.
* Reviewing promotional material for medicinal products.
* Preparing Module 1 documentation for National Applications.
* Preparing for and participating in meetings with Regulatory Authorities.
* Dealing with regulatory aspects of internationalising products and applying for reclassification.
* Training and mentoring more junior team members on Regulatory processes and compliance requirements.
* Monitoring and interpreting regulatory trends and changes relevant to the industry, keeping the company appraised of these.
What You'll Bring:
Our client is looking for a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs.
* Essential Experience & Knowledge:
* 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.
What’s On Offer:
* Competitive Salary: A highly competitive salary, negotiable based on your experience.
* Performance-Based Bonuses: Your hard work and contributions will be recognised and rewarded through performance-based bonuses.
* Hybrid Working: The company embraces a hybrid working model, requiring you in their offices near Dunboyne, Co. Meath three days a week, with flexibility for remote work 2 days per week. They also offer flexible start and finish times around their contracted 9-5 hours to help avoid peak traffic.
* Career Progression: With a turnover of €250 million and ambitious growth plans, the opportunities for professional development and career advancement within the company are significant.
If you're a seasoned Regulatory Affairs professional looking for a challenging yet rewarding role within a rapidly expanding pharmaceutical group, we encourage you to apply!
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Science, Quality Assurance, and Research
* Industries
Pharmaceutical Manufacturing
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