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Regulatory Affairs Manager

4 weeks ago

Dublin, Dublin City, Ireland Amicus Search & Recruitment Full time

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

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