Manager Regulatory Affairs
myTomorrows is an independent, globally operating organization based in the Netherlands. We provide patients with unmet medical needs and their doctors with information about treatment options worldwide and facilitate access to medicines in development.
We are changing the world of healthcare
By digitizing, organizing and making accessible key healthcare information, we can make a real difference to real people with real illnesses, all over the world. Our goal is to ensure that patients and doctors don’t miss out on treatment options due to lack of information, understanding and administrative hurdles. Through our efforts to support patients and their doctors, we believe we can help patients from all around the globe.
What will you do – Manager Regulatory Affairs
To strengthen our team, we are looking for an experienced Manager Regulatory Affairs to add value to our business. You will primarily be responsible for the development and execution of regulatory strategies, quality and compliance of early access programs and associated operational and submission activities. You are a team player, open-minded and willing to share your ideas and expertise in an international environment.
So, in short, in this role you:
- Develop regulatory strategies and perform feasibility assessments per product per country. Moreover you are responsible for compliant execution of an EAP in a country;
- Build the required high quality dossiers for EAP applications in collaboration with the Originator (biotech or pharmaceutical company) and the myTomorrows team. You are proud of getting results by meeting country specific requirements and being compliant with national and international regulations;
- Act as the primary point of contact for authorities and licensors for regulatory issues. You act as a Subject Matter Expert to internal and external stakeholder by providing regulatory advice on potential products suitable for EAPs;
- You base your decision making process on ethics and integrity. You create associations of trust and respect with key stakeholders.
As our new Manager Regulatory Affairs you are looking for a job where you are allowed to think yourself and define the process and pathway to support the business objectives: help the patients to get some more tomorrows. If you want to execute the SOP defined by your collegues, we don’t have a match. We do seek a self-starter. You have focus on continuous improvement, flexible attitude, drive and resilience and you are able to adapt to and manage change. Furthermore, you are fluent in Dutch and English.
Furthermore you have:
- A relevant master degree or higher;
- At least 5 years of relevant international work experience within the (bio)pharmaceutical industry and at least 2 years in Regulatory position;
- Preferarabely experience in named patient programs or compassionate use;
- A ‘can do’-attitide: always look for ways to help patients within the compliant national and international framework;
- A high degree of professional ethics, integrity and gravitas, which you combine with first class interpersonal and communication skills.
Compensation & Benefits
Our team is driven, caring, and determined. While we come from different backgrounds and disciplines, each member of our team contributes expertise that, combined with our technology platform, provides patients and their doctors the keys to drive the necessary change.
Other than working with a great team of young, smart and energetic people, we also offer:
- A competitive benefits package;
- An open and friendly work environment where we empower people and provide them with opportunities to develop themselves and their career;
- Friday afternoon drinks and various nice events.
Please send your application to email@example.com. For questions please feel free to contact Sanne Scheffers via firstname.lastname@example.org.