HYLORIS DEVELOPMENTS SA
Regulatory Affairs/CMC Specialist
We are currently looking for a Regulatory Affairs/CMC Specialist. The successful candidate will be responsible for the development of regulatory affairs strategies specific to quality dossiers, and submission and negotiation of regulatory submissions from clinical trial to post-market stage.
The job description
As Regulatory Affairs/CMC Specialist you will:
- Work as a strong partner with the VP Regulatory affairs and the R&D team to manage and advise on CMC
aspects of the developments.
- Provide advice and gap analysis during product development, tech transfer and lead dossier compilation.
- Organize scientific advice meetings with regulatory authorities, in particular the FDA.
- Manage responses to deficiencies, and post-approval changes.
- Review in detail all NDA 505(b)(2) dossiers in accordance with US FDA standards and completeness of eCTD modules (Modules 2, 3 & 5).
- Oversee all our dossiers and make sure we consistently attain Acceptance to File from FDA.
- Develop and document principles for pragmatic, business focused, efficient, and balanced CMC strategies for projects based on project value, project cost and the current regulatory environment.
- Supervise external manufacturing and development partners on matters related to RA/CMC for relevant projects.
Your professional profile
- Master’s degree or higher in Science or related field. Minimum 10 years of experience with regulatory affairs in the US and at least 5 years of experience in CMC review of scientific aspects required for compiling data on pharmaceutical products for 505(b)(2) submissions.
- Deep understanding of current regulatory requirements mainly for injectable products, analytical development, validation and testing, stability evaluation, etc.,
- Thorough understanding the dynamics of the regulatory environment in the US within and beyond FDA guidelines paired with ability to translate this into development tasks for all projects at Hyloris.
- A strong track record achieving 505(b)(2) filings and approvals within the agreed timelines.
- Languages: English. French or Dutch is an asset.
- Strong skills in chemistry and drug product formulation as well as robust knowledge of manufacturing facilities, manufacturing technologies, processes, and equipment, mainly in the injectable field.
- Strong analytical skills, enabler.
- A collaborative and independent working style, building partnerships among key stakeholders.
- Strong track record with the FDA processes and requirements for 505b2 NDA submissions.
ABOUT OUR COMPANY
Based in Liège, Belgium, Hyloris is an early-stage innovative specialty pharmaceutical company focused on adding value to the healthcare system by reformulating well-known pharmaceuticals. Hyloris develops proprietary products it believes offer significant advantages compared to currently available alternatives, with the aim to address the underserved medical needs of patients, hospitals, physicians, payors and other stakeholders in the healthcare system.
Hyloris has a robust management team with a success track record from many years in the pharmaceutical industry. We have a full operational structure with departments for Business Development, R&D, Regulatory, Medical Affairs and Licensing.
Hyloris is listed on Euronext Brussels.
Our talented staff work in accordance with our company values:
- We are proud of our entrepreneurial culture and foster open communication, mutual respect, professionalism and efficient decision-making and we believe that our multicultural organisation is one of our most important competitive advantages.
- We believe that timely and well considered decisions as a response to emerging opportunities and ideas is the key to our success.
- We believe that the success of the company lies in the competence, dedication and motivation of each of our employees.
- We believe that freedom returns flexibility and empowerment returns commitment.
For more information about our company, please our website here www.hyloris.com. Motivation letter and CV can be sent to firstname.lastname@example.org.