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Abacus Medicine Group

Regulatory Affairs Manager (Notification team)

Budapest, HungaryPosted Yesterday
onsite

Job Description

Drive meaningful change as a Regulatory Manager!


You will be responsible for managing one of the teams in the Regulatory department on the new product application and maintenance processes for parallel trading. You will proactively lead 4 coordinators in your team.
Your team will be responsible for printing and assembling packaging materials for medicines in cooperation with colleagues who are acquiring marketing authorization for parallel import in the EU. You will closely work with other Packaging Designers and other Regulatory Coordinators in the department.

Our aim is also to create efficient re-packaging methods for our different production sites, and you will have a key role in enabling this.
We consistently evaluate our operational processes, and your role will be to implement the necessary optimizations to ensure efficiency and excellence, while guaranteeing continuous improvement.

Your tasks shall involve:

  • Support Regulatory Management with strategy implementation to ensure high quality output and meet stakeholder expectations;

  • Continuous development of the Packaging Design function;

  • Provide packaging design expertise through an in-depth understanding and experience;

  • Participate in the change management of increasing efficiency in packaging activities;

  • Stay up to date with internal and external expectations;

  • Take responsibility for Packaging Design creation related internal procedures and managing improvements;

  • Responsible for team capacity management;

  • Being able to manage stakeholders, priorities in a demanding environment;

  • Focus on employee satisfaction.

  • Working in Photoshop, Adobe Illustrator and with addition of Office 365.


About You, our new colleague

  • Have proven experience in a similar or relevant role;

  • Have experience in packaging creation and/or work within printing houses;

  • Are educated to degree level: a bachelor's degree;

  • Have 3+ years' experience in leader position;

  • Fluent in English and Hungarian (written and verbal communication skills);

  • Are very structured .

Skills we seek:

  • Encouraging others in the immediate work environment to behave effectively, partly by showing exemplary behavior.

  • Inspire others throughout the organization to engage in effective behavior by creating preconditions and displaying exemplary behavior.

  • Provides direction and guidance to different individuals within the department in a way that leads to optimal mutual results and alignment.

  • Communicates effectively both verbally and written to achieve the intended result. Knows how to apply the right technique in every situation and switches when necessary.

  • Encourages others to show proactive entrepreneurship. Helps them to do this by giving feedback on their behavior. Sees opportunities for the company and follows up. Take action to improve the quality of service.

  • Result driven. Monitor results, accountable regarding achieving results and steers on output.

Competencies:

  • Excellent communication and stakeholder management skills.

  • Strong problem-solving abilities and capable of identifying issues and implementing solutions.

  • Open-minded and adaptable, comfortable working in a fast-paced and ambiguous environment.

  • Business risk mindset (evaluation) and impact on own team and company

  • Ability to navigate complex cross-functional environments with agility.

  • Experienced in: Salary adjustment, development plans, performance evaluation

  • Experienced in Hire, onboarding, PIP (personal improvement plan), offboarding

  • Plan and facilitate team meetings, with a clear agenda and actions

  • Understands the importance of Compliance and having a mindset on compliance excellence

  • Detail-oriented while maintaining a high-level value chain perspective.

  • Challenges the status quo to identify smarter, more efficient regulatory pathways

Be part of an international community of people who care!

Interested?

If you want to apply for the position, please follow the link and attach your CV.

Would you like to know more about us?

Follow us on Instagram and LinkedIn and get an insight into everyday life at Abacus Medicine. For job openings, check our Career page.

Moving Healthcare. Moving You.

In Abacus Medicine Group, you’ll experience the power of Moving Healthcare. With our change mindset, we're moving the industry and improving healthcare as we broaden access to medicine.

But it's not just about moving healthcare, it's about Moving You. You’ll be part of a caring community of more than 1,750 people across the World. With us, you will be valued, empowered, and have a direct impact on driving change. Let's access the future of medicine and make a difference together. Your move.

Regulatory Affairs Manager (Notification team) at Abacus Medicine Group | Renata