Regulatory MA Deputy Manager
2 weeks ago
Drive meaningful change in Regulatory Marketing Authorization
In Regulatory, we obtain licenses for parallel trading of medicine. We do this by submitting applications to the European Medicines Agency and national medicine agencies of our sales countries.
Our department is responsible for making sure that Abacus Medicine can parallel trade medicines as fast as possible while maintaining our obtained licenses.
Your responsibilities as a Deputy Manager
You will be responsible for managing one of the three teams in the Regulatory Marketing Authorization department on the new application and maintenance processes for parallel trading. You will proactively lead ~twenty colleagues in a team to create applications for new and existing product licenses for medicines to Authorities. You will lead optimization measures to be able to meet our KPIs and meet the needs of our commercial department.
Your main responsibilities include:
- Responsible for meeting KPIs within the team;
- Leading PI license applications and the maintenance thereof;
- Support the Regulatory and Product Development Management with strategy implementation to ensure quality and meet stakeholder expectations;
- Continuous development of the parallel distribution marketing authorization function;
- Provide regulatory expertise through an in-depth understanding and experience;
- Participate in the change management of increasing efficiency in licensing activities;
- Keep up to date with internal and external expectations;
- Take the responsibility of internal procedures and managing improvements;
- Responsible for team capacity management;
- Focus on employee satisfaction.
Skills and personality that will make you succeed
We are on the lookout for a dynamic leader with excellent communication skills and confident management abilities. The ideal candidate will be an outstanding people manager, providing clear guidance and constructive feedback to his or her team. To drive success and foster a collaborative working environment, strong interpersonal skills and a flair for innovative thinking are essential.
In addition, we expect that you:
- Have proven experience in a similar or relevant role;
- Have experience in structured administrative tasks;
- Are educated to degree level: a bachelor's degree, preferably in pharmaceutics or regulatory affairs;
- Have 1+ years' experience in a leadership position, preferably in pharma/biotech and/or a pharma service organization;
- Fluent in English (written and verbal communication skills).
Realise your opportunities with people who care
The team consists of 60 colleagues who are experts in the regulatory requirements needed to do parallel trade in each of the markets we are currently selling. We coordinate daily with several internal and external stakeholders to make sure that we are applying for the right licenses at the right time, receive them as fast as possible, and that we will be producing products according to regulations. This requires us to be knowledgeable and to have good stakeholder management skills. On top of living up to our goals and requirements, we are an inclusive and friendly group of colleagues who are happy to help each other and share lunch together.
What we offer:
- Support for work-life balance, flexible management approach;
- Abacus is a long-term opportunity, we encourage your professional development with internal job opportunities and trainings;
- Semi-annual company bonus;
- Cafeteria with optional elements;
- Annual salary increase;
- Employee referral program with high rewards;
- AYCM SportPass membership opportunity;
- Private health insurance package provided by Medicover after 6 months of employment.
Working Flexibility:
We believe in hybrid working. The team spends 2 days in Home Office and are present at the Kerepesit street office 3 days a week.
Are You applying as an Employee Referral?
If you have been introduced to our company by one of our employees, please select the 'Referred by a friend / network' category at 'Referencia' section. You can provide the name of your referrer at 'Megjegyzés' field.
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 1,300 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.
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.
If you want to apply for the position, please follow the link and attach your CV and cover letter.
Application Deadline: Monday, September 30, 2024
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Deputy Regulatory Affairs Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark ABACUS MEDICINE AS Full timeIn this role as Deputy Regulatory Affairs Manager, you will be part of our team that coordinates daily with internal and external stakeholders to ensure we obtain licenses for parallel trading of medicines. Our department is responsible for making sure Abacus Medicine can parallel trade medicines as fast as possible while maintaining our obtained licenses.
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