Specialist / Manager, Regulatory Affairs
The Regulatory Affairs Specialist/Manager, provides active scientific contributions to a cross-functional clinical team developing compounds currently being studied for new chemical entity applications and biologics applications. This position will support couple early stage development candidates. Activities include supporting the strategic design, execution, and interpretation of key clinical studies supporting high-priority corporate initiatives. The individual who assumes this high-visibility position will interact both with cross-functional teams within and externally to Klus Pharma Inc., and other divisions of Sichuan Kelun Pharmaceutical Research Institute Co., Ltd
- Provide strategic and tactical direction to multiple project teams
- Evaluate new CROs and other vendors for conforming with KLUS Pharma Inc. quality controls.
- Review, summarize and integrate complex data sets across multiple disciplines.
- Manage the preparation and presentation of nonclinical safety data for project teams, portfolio management presentations, and internal /external partners and scientific groups.
- Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of results on program and clinical/regulatory strategy.
- Generate yearly budgets to support programs.
- Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates and work closely with Research to develop program budgets.
- Maintain a current understanding of regulatory requirements and guidance.
- Identify requirements and direct the implementation of new regulatory policies and procedures and processes, as needed.
- Direct and coordinate the composition of regulatory submissions including INDs, NDAs, BLAs and FDA meeting requests and briefing documents to ensure all submissions meet FDA expectations as described in current guidance and comply with applicable regulations.
- Provide effective management and oversight of the commercial product portfolio by ensuring compliance with post-approval regulatory filing requirements for NDAs, INDs, BLAs including review and approval of post-approval changes.
- Develop and implement regulatory project time lines for pre- and post-approval submissions that align with corporate goals and insure adherence to pre-established project time lines by effectively managing departmental and external resources.
- Serve as the Regulatory Affairs Representative on project teams.
- Provide strategic regulatory guidance to internal and external stakeholders for the R&D and commercial product portfolios and insure cross-functional strategies are in alignment.
- Maintain awareness and communicate with key stakeholders regarding evolving regulatory requirements.
- Bachelor’s degree is a must, and advanced degrees are preferred
- Significant knowledge of basic research and CMC and its application to drug development is important.
- Understanding of drug trial design, authoring and successful implementation of clinical protocols and clinical study reports
- Strong experience reviewing & interpreting study data/reports and presenting findings to project team members.
- Excellent organizational, written and oral communications skills.
- Demonstrated experience in scientific writing.
- Demonstrated ability to effectively work with a diverse range of people.
- Ability to quickly adapt to a changing work environment; comfortable with ambiguity in a start-up environment.
- Possesses a collaborative, results-driven style.
- Ability to motivate, collaborate and provide leadership in a growing enterprise.
- Exhibits integrity, honesty and a sense of personal accountability.
- Proficient in office-based computer skills including Word, Excel, PowerPoint, etc.
- Specialist will have 1-3 years, Manager will have 5+ years or Pharmaceutical and/or Biotech experience.
- Oncology experience is preferred
- Biotech experience is a plus.
About Klus Pharma:
Founded in 2014 as a wholly owned subsidiary of Kelun Group and affiliated company of Kelun-Biotech, KLUS Pharma is committed to the discovery and development of innovative biotherapeutics. Our top priority is to address the unmet needs of patients suffering from cancer, cardiovascular disease, autoimmune disease, and other severe disorders due to lack of effective treatment options. Utilizing our innovative technology platforms for monoclonal antibodies, bi-specific antibodies, and Antibody-Drug Conjugates (ADCs), we have advanced multiple biologic programs into the clinical stage to treat these debilitating conditions.
KLUS Pharma has streamlined antibody discovery and engineering capabilities, which enable a seamless transition from target discovery to product development. Our team of industry experts in immuno-oncology, immunology, and cardiology, can rapidly advance biological drug candidates from bench to market. KLUS Pharma has identified and assessed dozens of therapeutic targets and is currently conducting preclinical and clinical studies for more than 10 antibody-based therapeutics.
Learn more here
Job posted: 2021-03-13