Magnet.me  -  The smart network where hbo and wo students find their internship and first job.

The smart network where hbo and wo students find their internship and first job.

This opportunity has expired. It is therefore no longer possible to like or apply.

See similar opportunities instead

Manager Regulatory Affairs

Posted 22 Mar 2024
Work experience
2 to 5 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

Your career starts on Magnet.me

Create a profile and receive smart job recommendations based on your liked jobs.

myTomorrows is an Amsterdam-based health-tech company specializing in pre-approval access. We help patients with an unmet medical need to discover, find and access treatments in development. We are determined to solve the extremely complex puzzle of equitably connecting as many patients as possible with innovations in medicine.

Over the last seven years myTomorrows has helped more than 5,000 patients around the world and has partnered with over 30 pharma and biotech companies to facilitate access to treatment. With offices in Amsterdam and New York our team is as diverse as our patient base and we’re excited to continue offering a product and service that makes a difference globally. At myTomorrows wherever you are, whichever role you play, you’re guaranteed to share your day with committed, inspired, and resourceful teammates.

Your opportunity

The task of facilitating access to treatment for patients with an unmet medical need involves gathering individuals from a wide range of pharma, medical, tech and business fields. In this incredibly dynamic environment, we are looking for a team player with the same values, right skill set and motivation.

Our ideal candidate is a self-motivated professional who enjoys navigating the complex global landscapes of regulatory affairs and pre-approval access.

What you’ll do

As Manager Regulatory Affairs at myTomorrows, you will:

  • Represent myTomorrows’ Regulatory Affairs in various situations: discussions with Regulatory Authorities and clients (pharmaceutical companies), cross-functional internal meetings and internal/external audits;
  • Support Physicians in their submissions of applications for pre-approval access to Regulatory Authorities worldwide;
  • Compile dossiers and submit applications for Expanded Access/Compassionate Use cohort programs worldwide;
  • Create and review regulatory content;
  • Manage regulatory aspects of Early Access Programs in collaboration with the Medical and Project Management teams and Manufacturers;
  • Develop, maintain and execute regulatory strategies of Early Access Programs in line with national and international regulations;
  • Maintain the Regulatory Intelligence repository for Early Access requirements worldwide;
  • Research the requirements for regulatory affairs Early Access in new markets;
  • Advise on pre-MAA regulatory strategies, including scenarios for the earliest market access (including risk assessment);
  • Ensure proper and timely archiving of Early Access dossiers;
  • Ensure regulatoy affairs compliance of the Early Access medication supply;
  • Create and maintain allocated SOPs;
  • Report to the Senior Manager Regulatory Affairs.

What you have

  • 2+ years of Regulatory Affairs experience within the pharmaceutical industry or Contract Research Organization (CRO), preferably in a client-facing role;
  • Extensive knowledge of (European or International) Regulatory Affairs with experience in at least one of the following areas: Clinical Trials, Early Access, Marketing Authorization Application procedures, Post-Trial Access. Early Access experience is preferred;
  • Excellent time management skills;
  • Excellent verbal and written communication and networking skills;
  • Knowledge of at least one additional language, besides English (considered a plus).

In addition to the above, you are:

  • Attentive to detail and you use a structured decision-making approach
  • Self-motivated, result-oriented, flexible, a builder at heart with a "get it done" attitude
  • Able to:
  • prioritize
  • analyze problems, identify and recommend alternative solutions
  • optimize current processes and think along with the team and clients;
  • work cross-functionally at all levels
  • work with projects of varying size and scope, independently or in a team

Life at myTomorrows

We're on a mission to forever change the face of pre-approval access and touch the lives of patients. To do this we have assembled an eclectic and energetic team. Working at myTomorrows connects you with amazing people and purpose.

myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated.

The best work comes from our best selves and we go to great lengths in supporting our employees to be just that.

myTomorrows is an independent, globally operating organization based in the Netherlands. We provide patients with unmet medical needs, and their doctors, information about treatment options worldwide and facilitate access to medicines in development.

Healthcare
Amsterdam
Active in 2 countries
60 employees
40% men - 60% women
Average age is 35 years