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.
As VP Regulatory Affairs, you will:
- Manage the complete RA process, from project nomination until regulatory approval.
- Determine regulatory strategies for the Company’s products.
- Steer and manage the regulatory actions, including pre-INDs, INDs , 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
- Master’s Degree or higher in Science or related field.
- Minimum 15 years of experience with regulatory affairs in the U.S. 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 related to Quality by Design, manufacturing process mainly for injectable products, analytical development, validation and testing, stability evaluation, etc.
- Thorough understanding of the dynamic regulatory environment in the U.S., including prompt awareness of new guidances, draft guidances, trends and the current thinking of the FDA with ability to translate this environment into specific actions for each development project of Hyloris.
- A strong scientific track record of delivering key development milestones, leading to 505 (b)(2) NDA 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 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.
- Organisational 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
Hyloris is a specialty biopharma company identifying and unlocking hidden potential in existing medications for the benefit of patients and the healthcare system. Hyloris applies its knowhow and technological innovations to existing pharmaceuticals and has built a broad proprietary product pipeline that has the potential to offer significant advantages over currently available alternatives. Hyloris currently has two partnered, commercial-stage products: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid analgesic for the treatment of pain. The Company’s development strategy primarily focuses on the FDA’s 505(b)2 regulatory pathway, which is specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This pathway can reduce the clinical burden required to bring a product to market, and significantly shorten the development timelines and reduce costs and risks. Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn.
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.