Want to join a dynamic startup and make your work count?
Legal Counsel and Regulatory Expert
Join a dynamic, disruptive, multicultural and mission-driven healthcare startup, located in a beautiful shared office-space building located in the heart of Amsterdam, on one of Amsterdam’s most beautiful canal streets.
TheSocialMedwork is a social enterprise that helps patients from all around the world gain access to the latest and most innovative approved medicines to fight their cancer, MS, ALS, Alzheimer’s, and more. Patients browse these medicines via our online platform and then reach out to us for information and support in sourcing them.
Millions of patients suffer or die needlessly because they’re unable to get their hands on the best and newest personalised treatments in their own country. We intend to change that for the better of patients worldwide.
Is it going be difficult? For sure! Is it worth it? Absolutely!
We work hard, play with passion, celebrate life and aim to change the world!
The Legal Counsel and Regulatory Expert for TheSocialMedwork,which operates globally, will be responsible of any legal matter occurring within the business operations. In this role, you ensure that the business practices and activities of TSM, and its partners, are in compliance with internal policy, local laws and regulations, relevant industry standards (e.g. The MedTech Europe Code of Ethical Business Practices) and applicable international laws. You will serve as a strategic business partner for the management team, and as a coach to all employees, to assure that the company is always compliant in its day-to-day business.
The Legal Counsel and Regulatory Expert is responsible in monitoring and ensuring compliance in regulatory activities associated with the national regulations for named patient import for unapproved medicines, including regulatory approvals for clinical trials and marketing applications, and the maintenance of these authorisations where appropriate. Further, the Legal Counsel and Regulatory Expert will handle any legal matter which arises related to the company’s operations. In these instances you will be the contact person for external lawyers if those services are needed.
You are a team player, hands-on and have a can-do mentality. You are one of these hard to find lawyers who actually make things happen!
- Maintaining regulatory database
- General legal affairs
- Data protection law
- Ongoing team training
- Due diligence
- Consulting with appropriate departments where necessary
- Cooperating with law firms on selected matters
- Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice.
- Management of regulatory activities
- Maintaining the contract database
- Negotiating partnerships on behalf of the company
- Law degree with a minimum of 5 years experience in regulatory affairs in the pharmaceutical industry
- Expert regulatory knowledge
- Good legal generalist
- Can-do and hands-on mentality
- Team player
- Excellent English
- Living in Amsterdam or willing to relocate
What’s waiting for you:
In this role, you will have a great opportunity to further develop as an all-round in-house Legal Counsel within a fast growing company in a dynamic international environment. You will have the chance to look into different areas of lawat an international level. As a Legal Counsel and Regulatory Expert you will work directly with the COO and CEO.
- A full time role and the opportunity to grow (40 hrs/week)
- 25 days holidays as long as you promise to come back!
- An entrepreneurial and multicultural team environment with a flat, hands on organisational culture, and a ‘work hard, play hard’ mentality (lunch, drinks, fun)
- Doing something impactful
- Energising and fun colleagues
- Start: ASAP
If this sounds like the job for you, please send your CV and Cover Letter to email@example.com, fao. Katrin Schepp