Job Title: Director, Regulatory Affairs

Department: Regulatory Affairs

Location: Remote UK

Overview of Role: 

Reporting to Senior Director of Regulatory Affairs, the Director of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects with an in-depth knowledge and understanding of the regulatory environment, European regulatory expertise is required. 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. 

Role and Responsibilities: 

• Provides strategic European regulatory guidance on project teams globally and key sub-teams at study level, by proactively assess, develop, and implement competitive regulatory strategies in EU in alignment with other regions for ivonescimab, and identify potential risks and mitigation steps with proposed strategies. 

• Owns regulatory activities at molecule and study-level, including timelines, clinical trial application (CTA) review, approval of investigator document packages and other associated EU submissions. Manage other day-to-day regulatory activities of the studies as necessary and independently.   

• Leads and presents impactful regulatory assessments and regulatory recommendations to study team and senior leadership by providing interpretation and application of regulatory requirements. 

• Acts independently under the direction of Senior Director or TA Regulatory Head, while ensuring alignment of global regulatory strategy with senior leadership.  Based on experience and scientific strength, expands knowledge of therapeutic area. 

• Health authority (HA) meetings:  Serves as health authority (HA) liaison with EMA/CHMP for meetings.  Leads Project Team in the planning of regulatory meeting request and meeting package, coordinates and leads cross-functional regulatory defense preparation meetings, responses to health authority queries, and health authority meetings. 

• May have direct report(s) and contribute to performance management of other RA team members. 

• Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions and/or commitments. 

• Demonstrate expertise and knowledge of lung cancer and other indications as needed. 

• Manage emerging issues (e.g. new safety or quality finding) and associated risk communications to stakeholders.  Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessments. 

• Support non-program specific projects, such as department initiatives, training, etc. 

Experience, Education and Specialized Knowledge and Skills: 

• Prefer a graduate-level degree, e.g., MS, PhD or PharmD, BA/BS degree in the biological or health related sciences required  

• Relevant (bio) pharmaceutical industry experience, including 7+ years of experience in regulatory affairs, with expertise in working in a complex and matrix environment, and with multiple stakeholders. 

• Strong knowledge and depth of application of EU regulations, drug development process, and industry-standard practices.  

• Strong regulatory acumen with driving regulatory strategies on project teams, including expert negotiation skills, including ability to work under pressure and proactively, and build consensus cross-functionally and within regulatory affairs.   

• Ability to interpret and summarize clinical data in a regulatory context is required. 

• Expertise interfacing with multiple government regulatory agencies.  

• Excellent written, oral communications in English.   

• Strong clinical foundation and understanding of disease landscape under consideration. 

• Careful attention to detail; ability to organize, prioritize, and delegate assigned projects 

• Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred as well as ex-US HA interactions, meetings etc. 

• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable 

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