(Interim) Regulatory Affairs & Pharmacovigilance Manager at myTomorrows
Amsterdam, , Netherlands -
Full Time


Start Date

Immediate

Expiry Date

29 Oct, 25

Salary

0.0

Posted On

30 Jul, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

ABOUT MYTOMORROWS

myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options.
We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem.
We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection.
With a global footprint spanning 125 countries, to date, we’ve supported over 15,000 patients and 2,400 physicians, earning the trust of 50+ Biopharma companies.
Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today.

Responsibilities
  • Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs.
  • Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as well as cross-functional meetings and audits.
  • Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients.
  • Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how).
  • Collaborate with the Commercial team to support new EAPs.
  • Ensure timely and compliant handling of all regulatory and pharmacovigilance activities related to EAPs.
  • Stay up to date on relevant global laws, regulations, and guidelines impacting EAPs.
  • Assist in drafting, reviewing, and maintaining regulatory documentation and templates.
  • Liaise with the Pharmacovigilance service provider to ensure alignment and compliance.
  • Contribute to maintaining department documentation such as SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective and Preventive Actions).
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