VP (Head) Regulatory Affairs
- Flexible US / Europe
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
ProQR is currently looking for a VP (Head) Regulatory Affairs (Full-time) to join our team.
This is an excellent opportunity to join a well-funded Biotech company that has attracted a world-class management team where you will be responsible for directing all aspects of the design of clinical studies, helping with implementation of clinical trials, and preparation of reports relating to clinical trial outcomes.
Location: Flexible US / Europe
Reports to: Chief Medical Officer
- Overseeing all aspects of Regulatory Affairs in a small and dynamic publicly-listed company
- Sit on the Company’s Leadership Team and guide overall strategy
- Managing NDA and ex-US marketing authorisation processes, before, during and after initial submissions
- Managing IND and ex-US clinical trial approval processes
- Providing expert regulatory input to project teams and senior management to enable the development of optimal regulatory strategies for programs
- Obtaining and evaluating FDA and other regulatory agency advice and guidance on clinical development programs
- Ensuring regulatory compliance of all relevant activities including DSURs, public clinical trial reporting, marketing and promotional materials/activities, etc
- Leading key internal regulatory affairs functions, including Regulatory Compliance
- Managing relationships with key investigators and KOLs, building on established network and growing wider network of key stakeholders
- Supporting inward and outward corporate/program partnering activities
- From an operational perspective, responsibility also for:
1. Consultant/provider management
2. Milestone delivery
3. Budget management
4. Reporting and documentation
We expect our VP (Head) Regulatory Affairs to have:
- Post-graduate degree
- Expert regulatory knowledge in an area of Ophthalmology or Rare Disease
- Outstanding track record gained within pharma/biotech of regulatory strategy development and successful regulatory submissions, especially in US but ideally also ex-US
- Extensive experience of interfacing with, and influencing, key regulatory authorities
- Proven ability to write original scientific documents such as clinical summaries, NDA/MAA integrated summaries, safety update reports and internal reports
- Strong record of positive collaboration with clinical, marketing and commercial teams in pharma
- Management experience as part of a senior leadership team responsible for strategy development
- Meticulous management – always ensuring on-time
- Ideally, experience of working with world-class, large pharmaceutical businesses, combined with exposure to smaller companies, with an understanding of the challenges facing an innovative company going through rapid growth.
Knowledge, skills, abilities:
- Excellent leadership skills that focus on teamwork and building alliances
- Strong willingness to work collaboratively with Commercial and Clinical departments to optimize product opportunities
- Demonstrable strategic vision, with the ability to plan forward and to implement, in order to achieve the goals that embody the vision of the Company
- The ability to operate effectively in a dynamic and entrepreneurial environment
- Flexibility, integrity and a clear sense of accountability
- Results-driven, with high level of tenacity, enthusiasm and energy
- Outstanding presentation and communication skills
- Intellectual rigour, insightfulness and sound judgement
- Self-sufficiency and the ability to ‘think outside the box’
- Willingness to undertake regular US and international travel
- The propensity to seek, and to act on, advice
- High level of motivation, confidence and initiative
- An agile mind, with the ability to set a clear plan – and to deliver on it
- A ProQRian; collaborative, positive, motivated to make a difference to the lives of patients and their families.
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
- A competitive salary including 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premium-free pension plan
- A commuting allowance
- A subsidized staff restaurant
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position.
You can contact Yessica De Brouwer via firstname.lastname@example.org if you have any questions.
Please note that a screening is part of our selection procedure.