Career Opportunities with Summit Therapeutics Sub, Inc. A great place to work. Careers At Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. *Position will be on-site. Relocation support will be considered for this role. Overview of Role: Reporting to European Regulatory Director, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned. The role is primarily home based out of: UK, Ireland, Germany, Belgium, Netherlands, Switzerland Role and Responsibilities: Provide ownership of projects and activities, including clinical trial applications (CTAs) and other European focused MAA pre-submission activities. Contribute and drive the regulatory content and strategy for marketing authorization submissions and pre-MAA submissions Provide regulatory guidance internally on study-team decisions Update study/project teams of regulatory activities in the context of study team management meetings Manage and track queries, commitments and submissions with reference to regulatory agencies, collaborate with subject matter experts to provide responses as necessary, provide periodic status updates regarding unfulfilled conditions/commitments Collaborate with cross-functional study team for planning of regulatory documents, including health authority meetings such as scientific advice, paediatric and/or orphan designation. Contribute to, or lead, internal meetings such as kick off meetings, cross functional project updates Manage/Support internal document processes, including reviewed, finalized, signed-off, and archiving General support of global / other region regulatory submissions and strategic planning as applicable Contribute to / and track regulatory compliance pre and post approval All other duties as assigned Experience, Education and Specialized Knowledge and Skills: BA/BS degree in the biological or health related sciences required, Master’s, PhD or PharmD preferred Minimum 3+ years of experience in Regulatory Affairs Minimum 7+ years of pharmaceutical, biotechnology or life science industry experience Knowledgeable of EMA and European guidance’s, regulations, drug development process, and industry-standard practices Possess strong written, oral communications Demonstrate proven interpersonal skills and experience working cross-functionally throughout the organization Detail-oriented, ability to work proactively, organize, prioritize, and delegate assigned projects Experience interacting with CROs e.g. CTAs, Clinical trial activations experience preferred Experience of EU/European health authority systems such as IRIS, CTIS is desirable Proficient user of standard MS Office suite (e.g., Word, Powerpoint, Excel), experience using electronic document management systems, and document review tools desirable Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit. #J-18808-Ljbffr
A leading biopharmaceutical company in Ireland is seeking a QA Manager to lead quality assurance activities and ensure compliance with EU GMP standards. The role involves overseeing remote batch release operations, managing audits, and collaborating with manufacturing and regulatory teams. A successful candidate will have a strong background in GMP regulations, a relevant degree, and over 5 years of experience. This is an exciting opportunity to work in a dynamic environment focused on innovative therapies. #J-18808-Ljbffr
A leading company in the pharmaceutical sector is seeking a Senior Manager of Regulatory Affairs to support regulatory activities across various projects. The ideal candidate will have extensive experience in regulatory submissions and a strong educational background in biological or health sciences. This role, primarily home-based, requires excellent communication, organizational skills, and the ability to work collaboratively. If you are detail-oriented and proactive, this is the perfect opportunity to advance your career in a dynamic environment. #J-18808-Ljbffr
Career Opportunities with Summit Therapeutics Sub, Inc. A great place to work. Careers At Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The QA Manager will lead and manage quality assurance activities to ensure compliance with EU GMP, regulatory requirements, and company standards. This role involves oversight of quality systems, batch release processes, audits, and continuous improvement initiatives. The QA Manager will act as a key liaison between manufacturing, regulatory, and quality teams tomaintainproduct integrity and patient safety. This position will also oversee quality systems, support product development and commercialization, and ensure that all activities align with Summit’s mission to deliver safe, effective therapies to patients. Role and Responsibilities: Oversee remote batch release operations, ensuring real-time quality oversight of manufacturing and testing conducted at global contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs).Manage batch documentation reviews and approvals using digital QMS platforms and electronic batch records (EBRs). Collaborate with CMOs, CDMOs, and supply chain partners to ensure seamlesssupportto theQualified Person (QP) in batch certification and release activities. Ensuretimelyreview and approval of batch records and associated documentation. Act as responsible person (RP) SME,is responsible forensuring that the product is transported,storedand delivered according to the license and in compliance with GDP regulations. In addition, the RPis responsible forensuring that the product is not tampered with, stolen or counterfeited during distribution. Maintain and improve the Pharmaceutical Quality System (PQS) in compliance with EU GMP and ICH guidelines. Oversee CAPA, change control, deviation management, and risk assessments for EU qualitysystem. Ensure compliance with EU GMP, ICH guidelines, HPRA, and EMA regulatory requirements. Provide leadership on quality assurance (QA) and quality management system (QMS) initiatives.Ensure SOPs and quality documentation are current and compliant. Deliver GMP training and supportjunior QA team members. Conduct audits of CMOs, CDMOs, and suppliers to ensure compliance with GMP standards. Prepare for and host regulatory inspections and internal/external audits. Implement corrective actions and continuous improvement plans. Experience, Education and Specialized Knowledge and Skills: BSc/MSc/PhD in Pharmaceutical Sciences, Chemistry, Biology, or related discipline Minimum5+ years of experience in a GMP-regulated environment within the pharmaceutical or biotechnology industry Experience in remote batch release, electronic batch records (EBRs), and digital QMS systems Strong knowledge of good distribution practices (GDP)with an RP background. Strong knowledge of EU regulatory requirements, HPRA/EMA expectations, and GMP compliance for global supply chains Experience in managing audits and regulatory inspections. Experience working with CMOs/CDMOs and managing outsourced manufacturing. Proven ability to lead and influence in a cross-functional, global team setting. Strong problem-solving skills and ability to manage complex quality issues remotely Excellent communication, leadership, and problem-solving skills. Experience in sterile manufacturing or biologics. Eligibility or aspiration to become a Qualified Person (QP). Experience working in a ‘virtual’ BioPharma company would be desirable but not essential. CMO Oversight experience would also be beneficial. What We Offer Competitive salary and benefits package. Opportunity to work in a dynamic, innovative environment. Career development and training support. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team atrecruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. #J-18808-Ljbffr
