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Regulatory affairs manager

Amicus Recruitment
Regulatory affairs manager
Posted: 14 June
Offer description

Group Regulatory Affairs Manager Pharmaceuticals (Hybrid) Location: Offices based near Dunboyne, Co. Meath, Ireland Our client is a thriving Irish pharmaceutical group experiencing significant growth. Through consistent organic expansion and strategic acquisitions they have built a strong portfolio of market-leading OTC and Prescription medicines. Their products are marketed across numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experienced Group Regulatory Affairs Manager to join their growing team. This is 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 the Group Regulatory Affairs Manager, you'll play a crucial role in ensuring the clients diverse product portfolio complies with global regulatory frameworks. This is a hands-on management position where you'll be expected to get stuck in and drive results. Your key responsibilities will include: Developing and implementing robust regulatory strategies to support product development and lifecycle management, particularly for our expanding portfolio acquired through acquisitions. Leading and mentoring a team of Regulatory Affairs Officers, fostering a collaborative and high-performing environment. Efficiently integrating all new portfolio acquisitions across multiple international markets. Spearheading projects to identify and resolve gaps in regulatory dossiers. Leading high-level meetings with Regulatory Authorities. Driving the regulatory aspects of internationalizing products and pursuing reclassification when appropriate. Proactively monitoring and interpreting global regulatory trends and changes, ensuring the company is always ahead of the curve. Collaborating cross-functionally with our Quality and Commercial/Marketing teams to achieve overarching company objectives. 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: 8-10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry (human health). Strong knowledge of global regulatory frameworks, including MRP, DCP, and CP procedures. Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries. A proactive, "roll up your sleeves" attitude with a strong drive to see tasks through to conclusion. Exceptional attention to detail and outstanding organisational skills. Ability to work autonomously, take initiative, and assume responsibility for your actions. Highly Desirable: Knowledge of medical device regulations. Experience with cosmetics regulations. Whats On Offer: Competitive Salary: A highly competitive salary, negotiable based on your experience. For a manager-level role like this. Performance-Based Bonuses: Your hard work and contributions will be recognized and rewarded through performance-based bonuses. Hybrid Working: Our client embraces a hybrid working model to offer flexibility while fostering team collaboration. You'll be required in their offices near Dunboyne, Co. Meath three days a week.They offerflexible 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! Benefits: Performance Bonus

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