Overview of Role:
The Director of Regulatory Affairs will perform the day-to-day regulatory work of the assigned projects under the direction of Senior Director of Regulatory Affairs, with specific emphasis on understanding the regulatory context, and knowledge of European regulations is particularly needed. 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 direction and oversees various project operation teams and a significant study team sub division on a global level by continually evaluating, planning and executing regulatory strategy in the EU for ivonescimab in consideration of the other regions and working to identify the potential pitfalls with the strategies put forward and how to prevent them.
Primarily responsible for regulatory related activities at molecule and study level including timelines, CTA review, approval of investigator document package and others for the regular studies of investigations and EU submission. Manage other day to day regulatory activities of the studies as necessary and with minimum supervision.
Proactively leads and summarizes the regulatory assessments, and provides recommendations to the study team and management by explaining and suggesting the applicability of the regulations to various initiatives and activities.
Acts autonomously within the guidelines of the Senior Director or TA Regulatory Head, with due regard to the agreement of senior management on the coordination of global regulatory proceedings. Increases knowledge of therapeutic area depending on experience and on scientific background as well.
Health authority (HA) meetings: Participates as HA contact point with EMA/CHMP in the interests of these meetings. Limits Project Team in the organization of regulatory meeting request and meeting package, organizes and takes part in cross – functional regulatory defense preparation meetings, answering health authority`s queries and health authority meetings.
May have people manager responsibility and assist in the talent management of other members of the RA team.
Plan and manage the queries and commitments responses to the regulatory bodies, write responses in collaboration with specialists to queries, provide information from time to time about the conditions and/or commitments that are still outstanding.
Exhibit expertise and knowledge of lung cancer as well as other indication(s) whenever required.
Act on emerging issues (new safety or quality finding for instance) that influence potential stakeholder risk and how these findings are communicated to stakeholders. Evaluate regulatory trends and developments apply them, identify the listed changes and determine whether they create any gaps and perform an impact analysis.
Assist in additional responsibilities that are out of scope of program targeted work, such as department projects, performing educational activities, 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.
Strong working knowledge of Word and Excel plus exposure to electronic document management systems and document review solutions preferred.
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