Regulatory Affairs Manager - Pharmaceuticals
Regulatory Affairs Manager - Pharmaceuticals
10 minutes ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Amicus Search & Recruitment
Senior Consultant, Sciences & Healthcare Recruitment @Amicus
Group Regulatory Affairs Manager – Pharmaceuticals (Hybrid)
Location: Offices based near Clonee, 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.
What’s 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!
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance and Science
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Amicus Search & Recruitment by 2x
Get notified about new Regulatory Affairs Manager jobs in County Meath, Ireland.
Clonee, County Meath, Ireland 3 weeks ago
Senior Regulatory Affairs Specialist - Pharma
Regulatory Affairs Specialist - Plant Protection Products
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr