Regulatory Submissions, Manager

Job Details: Regulatory Submissions, Manager

Full details of the job.

Vacancy Name

Vacancy Name Regulatory Submissions, Manager

Vacancy No

Vacancy No VN188

Employment Type

Employment Type Permanent

Location of role

Location of role Abingdon

About the Company

About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.

Key Responsibilities

Key Responsibilities MAIN PURPOSE OF JOB

The Submission Manager will manage regulatory operations activities of EU Clinical Trial Application (CTA) submissions in the Clinical Trials Information System (CTIS) in compliance with the EU Clinical Trial Regulation (EU CTR). In addition, other submissions in other countries/regions maybe assigned (US, UK, Canada, Australia, S. Korea, etc). The ideal candidate will have submission experience in the US, EU and ex-US/ROW (CTA/CTR). The individual will have a strong regulatory operations skill set for preparing regulatory submissions and managing tasks contracted to external vendors. The submission manager will interface primarily with the regulatory affairs team, 3rd party submission vendors and CROs, as well as individuals on the cross-functional program teams from Clinical, Clinical Operations, Safety, Quality, and Commercial.
The candidate will be responsible for managing the logistics, preparation, quality, and delivery of regulatory submissions in accordance with Regulatory Agency requirements, company standards, and timelines.
The individual will assist in assessment and implementation of process improvements (e.g., SOP review and creation) for the growing regulatory affairs and operations team.
This role will also require someone who can work within a highly innovative, agile, and entrepreneurial environment and is able to provide regulatory support for the program teams and Regulatory Affairs group.

KEY RESPONSIBILITIES

• Manage, prepare, co-ordinate and be responsible for the submission of regulatory documentation supporting submissions to the US, EU and ex-US/ROW health authorities, in support of CTAs/INDs, BLAs/MAAs, safety reports and updates, along with all other regulatory submissions for assigned project(s).
• Independently manage submissions of EU CTAs according to project plans set forth by the regulatory team lead via the Clinical Trial Information System (CTIS).
• Organize and manage the accurate transcription of metadata provided by regulatory leads for documents in CTIS and other corresponding information needed to support new and existing CTA.
• Manage the archiving of CTA documents from CTIS to RIM, including but not limited to, entering metadata and upload of documents and submissions.
• Oversee to the planning, compilation, and review of submissions to health authorities.
• Demonstrate leadership qualities through project management and mentoring junior Reg Ops staff.
• Work independently with interdisciplinary team members, manage timelines and compile documents for routine maintenance and major submissions with little oversight from Regulatory Operations Management
• Assist with the development of documents with various functional teams to plan, track and facilitate finalization of documents deliverables for use in regulatory submissions.
• Coordinate with the Regulatory Affairs Program Team representative in the planning and management of all aspects of regulatory submissions necessary to support program team activities.
• Working with both internal and external teams (including regulatory, CRO), as well as external consultants to ensure we meet the highest levels of compliance for all regulatory programs and related activities for assigned project(s).
• Responsible for ensuring that the electronic submission output complies with regional and country specific regulatory requirements as well as internal quality standards.
• Management of the dossier submission process, e.g., assessing what is required under regulations, outlining them to internal personnel and oversight of the preparation of dossier submissions, including maintenance, tracking, and operational coordination of electronic global regulatory submissions throughout a product's lifecycle.
• Provides regulatory operations guidance and information to regulatory leads and/or project teams as well as assessing, creating and implementing Regulatory systems/process improvements (e.g. SOP review and creation).
• Support the maintaining of archival files for regulatory affairs for documents that must have a controlled limited-access version maintained in a secure area.
• As assigned, perform quality control (QC) review of documents which are part of various regulatory submissions as per project requirements. Examples include to look for typographical, grammatical/spelling, formatting, flow and language and general clarity of text.
• Implement and become proficient in the Regulatory Information Management (RIMs) system.
• Support Head of Regulatory Operations in the assessment and implementation of process improvements, including but not limited to writing and reviewing SOPs to support Regulatory Affairs/Operations and Veeva RIM (e.g., SOP review and creation).

Experience & knowledge

Essential

• Solid track record in drug development and leadership of submissions that are compliant with health authority requirements for assigned project(s)
• Excellent knowledge of US and Global regulatory submission requirements
• Experience with EMA Clinical Trial Information System (CTIS)
• Experience working in Veeva Platforms, preferred.
• Experience representing Regulatory Affairs while working in cross functional teams
• Experience in supporting global clinical studies
• Ability to work on multiple projects, while maintaining quality and timelines, and able to prioritize workload with minimal supervision
• Ability to be agile to accommodate changing priorities
• Excellent communication and interpersonal skills
• Detailed oriented and highly organized
• Capable of creating and maintaining logical processes for tracking inventories and filing

Preferred Experience & knowledge

• Experience in managing, preparing, submitting INDs, CTA/CTRs, BLAs/NDAs, and MAAs. Contribution to part of the submission of at least 1 NME BLA/NDA is highly desirable, but not required.
• Experience in managing, preparing, submitting ROW submission types, desirable.

Education & qualifications

Minimum of 5-8 years’ experience in regulatory operations. #J-18808-Ljbffr

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