Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Numab Therapeutics AG is an expanding, clinical stage Swiss biotech company based in Horgen, Kanton Zürich. The company is focused on the discovery and development of innovative, antibody fragment-based therapeutics with a focus on inflammation and immuno-oncology. With our breakthrough antibody-discovery and multi-specifics engineering platform, we engage in proprietary projects as well as collaborative research on behalf of partners in the pharmaceutical industry.
Numab is seeking a contract Regulatory Manager to support the execution of regulatory activities in support of our global, clinical-stage development programs. This role will report to the VP of Clinical Operations and Regulatory Affairs. The ideal candidate will thrive in an energetic, fast-paced environment, working with highly motivated and passionate people. Applicants must have also demonstrated strong interpersonal and verbal communication skills.
Responsibilities:
To perform this job successfully an individual must be able to perform each essential function effectively:
Oversee preparation and filing of all regulatory documents globally, providing primary authoring and hands-on support as needed.
Provide oversight for the development of meeting request letters, briefing packages, and other materials in support of meetings with competent authorities (e.g., Scientific Advice meetings with EU regulatory bodies, Type A-C meetings with US FDA, PMDA Consultation) to ensure cross-regional consistency with regulatory strategy for our products.
Lead response strategy for regulatory-related inquiries from global regulatory agencies and ensure that issues are addressed in a timely manner.
Review and approve regulatory administrative documents prepared by Numab’s CRO partners in support of regulatory submissions.
Maintain regulatory dossiers and collaborate with established CRO partners on submission strategies for each country/region, including support for ongoing dossier maintenance (e.g., submission of SUSARs, annual and periodic reports, amendments to protocols, IBs, IMPDs, and other notification submissions as needed, etc.).
Anticipate and mitigate regulatory risks impacting development programs, providing clear guidance and recommendations to Numab management.
Maintain consistent oversight of regulatory deliverables, keeping Numab management and other internal stakeholders apprised of progress and providing interim updates on ongoing activities and current initiatives.
Minimum Qualifications:
BS/BA (or equivalent) in chemical/biological sciences or pharmacy; candidates with advanced degree (e.g., PhD, JD, MD, and/or PharmD) preferred.
5+ years’ experience in pharmaceutical/biotechnology industry and/or within a regulatory agency, with at least 3 years of direct regulatory management experience.
Early-stage biologic drug development experience preferred.
Familiarity with e-publishing systems for preparing regulatory submissions a plus.
Prior experience working at a small company with wide ranging related responsibilities is an advantage.
Ability to work independently and with flexibility to manage rapidly changing priorities in a fast-paced environment.
Experience working with CROs and/or external contractors is required.
Outstanding written and oral communication skills.
Demonstrated ability to balance multiple projects to achieve goals and meet deadlines and company expectations with a high level of quality.
Advanced user of MSOffice Suite (e.g., Word, Excel, Project, PowerPoint, Outlook).
Numab is an expanding, clinical-stage biopharmaceutical company that operates on three proprietary multi-specific platforms designed to develop differentiated immunotherapies for cancer and inflammation indications. The company has its main operations in the Zurich/Switzerland area.
With our breakthrough antibody discovery and engineering platforms, Numab has the capabilities to generate a research pipeline of next-generation antibody therapies. To date, we have progressed three programs into the clinic, with their lead asset NM26 in Phase I. This program is a bispecific antibody that targets IL-4Ra (type I and type II receptors) and IL-31 for the treatment of atopic dermatitis and is developed with Numab’s Japanese partner Kaken Pharmaceutical Co., Ltd. In addition, we are currently progressing with NM32 (targeting oncology indications) through the clinic.
Numab has been able to secure a number of global alliances and partnerships with leading Pharma companies to validate the platforms and achieve clinical POC for their programs. These include 3SBio/Sunshine Guojian, Boehringer Ingelheim, Eisai, CStone, Ono, Kaken, and Tillotts. Besides co-development collaborations, the compa...ny also offers its cutting-edge discovery engine to partners looking to develop innovative antibody-based therapeutics with multiple specificities, tailored half-lives, unrivalled potency, and ready to be taken into preclinical and process development.