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Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
POSITION SUMMARY
You will interface with Regulatory, Global Product Development, and with different Pfizer functional lines, providing project leadership and expertise in the execution of regulatory Clinical Trial Application (CTA) submissions to regional partners and selected Health Authorities (HA). You will work with contributing business lines to lead operational submissions execution for designated Clinical Trial Applications. You will be the regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.
KEY RESPONSIBILITIES
- Drive global submission management activities for their assigned assets. Partner 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 lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines
- Liaise 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.
- Manage 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).
- Ensure that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, eg., Competent Authority submission requirements
BASIC QUALIFICATIONS
- Bachelors degree in a pharmaceutical or related life sciences discipline
- Minimum of 5 years relevant pharmaceutical and/or clinical experience
- In-depth understanding and proven execution of CTA processes globally
- Proficiency with Microsoft Office
- Comprehensive understanding of ICH/GCP and EU Clinical Trial Directive
- Understanding of EU Clinical Trial Regulation
- Familiarity with pharmaceutical organizational structures, systems, and culture
- Strong written and verbal communication skills
Purpose
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.
Flexibility
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 is committed to celebrating this, in all its forms – 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. |
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