1+ months


Warsaw, IN 46580
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Working across multiple functional lines the incumbent will be the WRO interface to Regulatory and GPD partners within designated Therapeutic Areas (TA's), offering project leadership and expertise for regulatory Clinical Trial Applications (CTA's). Leading CTA kick off meetings, driving delivery whilst adhering to quality and compliance including external regulatory requirements and standards.

Accountable for operational management of national regulatory dossiers to designated Health Authorities (HA's), the incumbent will execute, through the use of standards and tools, designated operational tasks such as submission planning, document receipt, translation management, technical build and submittal to HA via or on behalf of the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations. Critical features of this role include the ability to successfully interface with multiple cultures and partner lines to deliver accurate planning and delivery of the CTA portfolio including initial application and subsequent lifecycle updates (compliance and maintenance).

**Position Purpose**

Provides an interface to Regulatory and GPD partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory CTA submissions to regional partners and selected Health Authorities.

The Global CTA Submission Manager (CTA-SM) is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.

The GSM may be assigned as a Hub Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected geography.

**Primary Responsibilities**

+ Drives global submission management activities for their assigned assets. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.

+ Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities

+ Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.

+ Liaises with Study Management, regarding essential core documents that cross both HA and EC submission and translation processes

+ Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

+ Responsible for the co-ordination of translations for core documents required for submission

+ Manages the compilation for core package build, contributing to CTA and authoring documentation as required

+ Acts as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, e.g., Competent Authority submission requirements

+ Coordinates submission production and assists with definition, development, and implementation of global submissions policies and technologies to meet evolving business needs.

+ Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

+ Serves as a major source of innovative ideas seeking and developing efficiencies and effectiveness within the Submissions process by collaboration with key customer and supplier groups and business partners,

+ Promotes professional development through mentoring and motivating colleagues.

+ Drives connectivity and implements refinements in the Emerging Markets partner model through collaboration with peers

+ Promotes the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.

+ Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor

+ Operates as single BU Liaison point of contact for RegionalRegulatory Leads and designated CTAs.

+ Leads the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at global and local level.

+ Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department

+ Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently

+ Considered a technical resource within the group

**Technical Skill Requirements**

+ Proven aptitude in leadership, problem solving and logistics

+ Ability to work on multiple highly complex projects simultaneously.

+ Demonstrated attention to detail.

+ Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.

+ In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.

+ Ability to operate seamlessly and influence direct and indirect reports, as well as across organizations.

**Qualifications (preferred education, experience, attributes)**

+ B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.

+ In-depth understanding and proven execution of CTA processes globally

+ Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards

+ Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive

+ Understanding of EU Clinical Trial Regulation Desirable

+ Familiarity with pharmaceutical organizational structures, systems, and culture is preferred


**Breakthroughs that change patients' lives** ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.


We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Regulatory Affairs

Posted: 2021-01-18 Expires: 2021-04-29
Sponsored by:
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