Regulatory Affairs CMC Manager at ProQR Therapeutics
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 140 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.
Our Global Regulatory Affairs department is currently looking for a Regulatory Affairs CMC Manager (full-time) to join our team.
Location: Leiden, NL or Cambridge, Massachusetts, US.
In the position of Regulatory Affairs CMC Manager, you will be accountable for the development and implementation of the Chemistry, Manufacturing & Control (CMC) regulatory strategy for one or more products in line with the objectives set by the project team and with the company regulatory strategy. You will also ensure that the strategy is designed to deliver a rapid approval with a desired label. You will manage regulatory aspects to ensure that development, manufacturing and distribution is in compliance with regulatory requirements. You will actively participate in the facilitation of effective partnerships within the regulatory affairs function of ProQR and the drug development teams. To accomplish this, the Regulatory Affairs CMC Manager works with other Regulatory staff and with teams to develop and execute the regulatory strategy in order to guide drug development into registration. Additionally, the Regulatory Affairs CMC Manager will assist and support senior Regulatory staff as required with interactions with FDA, EMA and other national Regulatory Authorities.
We expect our Regulatory Affairs CMC Manager to:
- ensure that the content, quality and format of regulatory submissions comply with applicable regulations and guidelines
- contribute to the design and implementation of the CMC development and commercial strategy for assigned products, in agreement with senior Regulatory staff
- work with CMC and Quality Assurance to ensure compliance in the development, manufacturing and distribution activities
- drive the preparation and maintenance of CMC sections of regulatory applications, including INDs, IMPDs, Scientific Advice, and NDA/MAAs, amendments, supplements and variations
- liaise with internal and external partners, including EMA, FDA and other Regulatory Authorities, and participate in/managing of Regulatory Authority meetings
- contribute to the implementation of systems and processes to enhance global business value, with as specific emphasis in compliance
- contribute to the monitoring of the regulatory landscape to keep abreast of new developments and effectively communicate them across the company
- promote a global mindset
Skills and competencies that are required for making the difference:
- Bachelor’s degree in pharmacy, biology, chemistry or related subject with a minimum of 7 years industry experience in regulatory affairs in the pharmaceutical/biotechnology industry
- Experience with complex variations for DS or DP, or contributed to an MAA or NDA
- Strategic leadership skills, with a strong ability to think strategically and critically evaluate regulatory risks in drug development activities
- Excellent knowledge and understanding of the US and EU regulatory environment
- Strong knowledge and experience in all phases of drug development and commercialization
- Experience in the NDA/MAA submission and peri-launch phases
- Strong ability to work effectively with multiple disciplines and personalities, both independently or collaboratively in a team structure
- Innovative, initiative, anticipating problems and effective problem solving, by providing creative solutions
- Able to work in a fast pace environment, strong project planning and management skills, able to prioritize multiple tasks
- Excellent oral and written communication skills
- A high level of professionalism, efficiency, and commitment
We offer an exciting and innovative working environment in a very committed organization, with competitive benefits, including an annual performance bonus, stock options, flexible working arrangements and unlimited (un)healthy snacks and drinks.
In hiring new ProQRians, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Do you want to be part of our devoted team of enthusiastic professionals? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible but before 31 January 2019 if you are interested in this position.
You can contact Laura Faber via email if you have any questions.
Please note that a screening is part of our selection procedure.