Increasing access to medicines for patients: Contributing to novel ventures that develop and produce medicines for rare diseases through collaboration
Orfenix is venture builder in the pharmaceutical industry, aiming to improve access to medicines for patients by changing the way we structure and finance drug development. We achieve our goals by actively setting up and managing (international) public-private partnerships of doctors, patient organisations, (academic) medical centres, non-governmental organisations, contract development and manufacturing organisations and social investors. The partnerships, often in the form of a dedicated venture, are generally focussed around developing one specific treatment. All parties in the partnership commit time and money to develop a treatment that is accessible for all patients.
Your role
In the role of Regulatory & Development Manager, you will be responsible for the creation, review and management of a wide range of clinical and regulatory documents. You will collaborate closely with and manage key stakeholders, including physicians, scientists, and CDMOs, to ensure the timely delivery of high-quality documentation that meets regulatory standards. You will also lead communications with regulatory authorities and manage the development of selected portfolio ventures.
From the start you will be actively involved in three to four ventures. These ventures focus on repurposing or reformulating treatments with the potential to significantly impact patients’ lives. This is a hands-on role that spans all phases of the regulatory development process, offering daily interaction with diverse partners and deep involvement in strategic planning and execution.
In your role, your responsibilities for the ventures will include, but are not limited to:
- Lead the development, writing, and editing of complex clinical and regulatory documents, including clinical study report, investigator brochure, data safety monitoring board charter, scientific advice briefing document, orphan drug designation application, marketing authorisation application, paediatric investigation plan.
- Submit the clinical and regulatory documents in the appropriate (EMA) systems.
- Collaborate with and maintain oversight of cross-functional external partners e.g. physicians, scientists, CDMOs, to ensure accurate and timely completion of documents.
- Select and oversee third party vendors supporting regulatory and medical writing activities.
- Ensure documents comply with regulatory guidelines and industry best practices.
- Manage multiple writing projects simultaneously, prioritizing tasks effectively to meet deadlines.
- Liaise with competent authorities and follow up on the feedback to a submission.
- Stay up to date with evolving industry trends, scientific developments, regulatory guidelines and requirements.
- Support the design of a clinical development program to identify the fastest route to marketing authorisation.
- Day to day management of selected portfolio ventures in the role of venture manager
- Represent the venture at scientific conferences and industry events.
- Administration of the venture, in collaboration with the external administrative office
- Budgeting and forecasting for the venture
- Prepare for and follow-up of shareholder meetings
- Identify potential funding opportunities and lead the drafting and submission of subsidy applications.
Apart from the responsibilities for the ventures, your responsibilities for Orfenix will include (not limited to):
- Contribute to the visibility of Orfenix
- Contribute to continuous improvement within Orfenix by identifying gaps and areas where standardised approaches may be implemented
Your profile
We are looking for a proactive team member who wants to work on a challenging project with a lot of freedom and responsibilities. We have the following requirements:
- You have an academic master’s degree in Pharmaceutical Sciences, Medicine, Biology or a comparable and relevant field
- You have 2-3 years relevant hands-on experience in regulatory writing
- You understand scientific concepts, have strong writing skills, and the ability to communicate complex information clearly and concisely
- You have an affinity with entrepreneurship under socially responsible conditions and want to make a real impact for patients
- You have a strong sense of responsibility and are able to work independently
- You want to learn as you go and are curious
- You are fluent in English and proficient in Dutch
What we offer
- (International) projects with a lot of interaction with doctors who are passionate about research, patient organisations, companies, and investors
- The opportunity to help shape the new private-public partnerships of the future
- An environment where you can grow and can continuously learn new skills
- A healthy mix of personal responsibility and teamwork
- A flexible working environment with office space in Leiden, the Netherlands
- A competitive remuneration at par with start-up industry, including the option of revenue sharing
Do you want to learn more about the company or the available position? Feel free to contact Vincent van der Wel at +31 (0) 6 814 333 19. Interested straight away? Send your CV and cover letter via the box below or via email to info@orfenix.com.