Regulatory Affairs CMC Manager
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.
Our Regulatory Affairs department is currently looking for a Regulatory Affairs CMC Manager (Full-time) to join our team.
The Regulatory Affairs department partners with Senior Management and the Drug Development Teams, to effect all the necessary regulatory activities needed to implement the agreed strategies, with the ultimate goal of achieve desired product attributes in the drug development process and the rapid approval of the dossier in desired territory, with a desired label. To accomplish this, the Regulatory Affairs CMC Manager works with different teams to execute the regulatory strategy as agreed with senior regulatory staff in order to help advance the drug development. Additionally, the Regulatory Affairs CMC Manager assists and support senior Regulatory staff as required with interactions with FDA, EMA and other national Regulatory Authorities.
The Regulatory Affairs CMC Manager will:
- Contribute to the CMC development and implementation of the regulatory strategy for the allocated products in line with the objectives set by the project team and with the Company regulatory strategy.
- Work with CMC and QA to ensure compliance in the development, manufacture and distribution activities.
- Coordinate and contribute to the writing, maintenance and submission of regulatory CMC documents in line with guidelines and regulations, including INDs, IMPDs, Scientific Advice, MAA/NDAs, amendments and supplements and variations.
- Coordinate publishing activities.
- Ensure that the quality, content, and format of regulatory submissions comply with applicable regulations and guidelines.
- Liaise with internal/external partners, including assisting with interactions with EMA, FDA and other Regulatory Authorities; contribute to/ manage Regulatory Authority meetings
- Maintain a vigilance of proposed changes. Actively communicate these matters to the appropriate internal parties. Suggest and collaborate on strategies for managing the change. Suggest areas of new opportunity brought about by these changes.
- Actively participate in the development of SOPs and internal standards.
- Contribute to the monitoring of the regulatory landscape to keep abreast of new developments and effectively communicate them across the company.
- Ensures that project/department milestones/goals are met and adhering to approved budgets.
Location: Leiden, NL.
We expect our Regulatory Affairs CMC Manager to have:
- Minimum of an undergraduate degree in a scientific discipline (B.Sc.), but a graduate degree (M.Sc., Ph.D.) is preferable
- Minimum of 5-8 years industry experience in regulatory related field in the pharmaceutical/biotechnology industry
- Ability to work in team structure, as well as independently
- Flexible, proactive attitude
- Ability to prioritize multiple tasks
- Ability to communicate effectively in both a written and verbal format.
- Ability to work effectively with multiple disciplines and personalities.
Skills and competencies that are required for making the difference:
- Analytical and accurate
- Flexible and resistant to change
- Hands-on mentality
- Being able to work in a fast pace environment
- Being able to prioritize multiple tasks
- Excellent knowledge of spoken and written English (and Dutch)
- A nice person :-)
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
- 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 for 30 November 2021 if you are interested in this position.
You can contact Yessica de Brouwer via email@example.com if you have any questions.
Please note that a screening is part of our selection procedure.