HYLORIS DEVELOPMENTS SA
Vice President Regulatory Affairs
We are currently looking for a Vice President Regulatory Affairs. The successful candidate will be responsible for
providing regulatory leadership and for the planning and oversight of all regulatory submissions from pre-submission
to approval of product(s)/application(s). He/she will be responsible for addressing data requirements to regulatory
authorities. This position will provide the regulatory and technical expertise into Hyloris’ development plans of its product
candidates. The Vice President Regulatory Affairs prepares for and expedites early and effective approval of
pharmaceutical new products in accordance with regulatory strategy.
The job description
As VP Regulatory Affairs, you will:
- Manage the complete RA process, from project nomination until regulatory approval
- Determine regulatory strategies for the company products.
- Steer and manage the regulatory actions, including pre-INDs, INDs etc. and 505 (b)(2) NDA submissions.Oversee occasional EU and ROW submissions.
- Lead, manage and develop the RA team.
- Support the R&D team with RA requirements.
- Work as a strong partner with the COO, the Executive Management Team, the Board, and external scientific
advisors to manage and advise on scientific aspects of proposed business strategies.
Your professional profile
- Minimum Qualification: Advanced degree (e.g. Master or PhD) in a technical subject (Engineering. Biology,
Physics, Chemistry or Pharmacy) and qualifications in IP Law (Law degree or Postgraduate Diploma in Law
or Postgraduate Certificate in IP Law).
- At least 12 years work experience, ideally in a research environment (university or R&D department) and a
technology transfer office or IP Law Firm.
- Proficiency in legal terminology and electronic databases.
- Experience in managing IP records and generating reports.
- Extensive knowledge of patent filing and review.
- Exceptional ability to perform research and keep track of deadlines.
- Ability to collaborate with others and work independently.
- Exceptional recordkeeping and communication skills.
- Languages: Good English skills is a must (written and oral).
- Strong skills in chemistry and drug product formulation as well as robust knowledge of manufacturing facilities, manufacturing technologies and equipment, their suitability and limitations, mainly in the injectable field.
- Strong analytical skills, good negotiator/diplomat, enabler.
- Strong interpersonal skills, a collaborative and trust enabling working style, building partnerships among key stakeholders
- Strong track record with the FDA processes and requirements for 505b2 NDA submissions including pre-IND submissions, IND and clinical matters.
- Organizational aptitude to build, lead and develop an outstanding team.
- Adaptability, flexibility, independence and resourcefulness to both lead a big vision strategy while also willing to roll-up-sleeves and multi-task in order to thrive in a growing environment.
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 email@example.com.