Senior Manager, Data Management
2 weeks ago
Apply locations United Kingdom - Walton Oaks Europe - Any Pfizer Site time type Full time posted on Posted Yesterday job requisition id 4909250 ROLE SUMMARY
We have an exciting opportunity for a Senior Manager to join our Global Regulatory Affairs Vaccines Team as regional EU Lead, Regional Regulatory Strategist (RRS). We are looking for candidates with a dynamic and agile profile and a scientific background, and strong clinical/safety regulatory experience.
Note this is not a regulatory CMC, labelling, or submissions role. As well as supporting the regulatory strategy from a regional perspective, you will partner with project teams and other customer groups to ensure regulatory requirements meet business needs.
Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer vaccines.
Reports to the Global Regulatory Portfolio Lead
Assist in developing and implementing key clinical/safety regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defence and regulatory compliance.
Contribute to regulatory strategy and operational activities for projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
Participate in Regulatory and cross functional teams working closely with Clinical, Safety, Medical, CMC, submissions, labelling and commercial colleagues for assigned projects/products.
With appropriate supervision, direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory Leads (CRLs)) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
You will represent Pfizer as an Approval Liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the Regulatory Liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.
As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe.
Develop ideas and lead projects across the division and develop plans to achieve objectives.
Develop regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management.
Understand local regulations and developing trends in the local regulatory environment of the countries that support and provide assessment of the impact to key stakeholders.
Maintain licenses in compliance with local regulations of the countries by ensuring that corporate regulatory processes, Standard Operating Procedures (SOP) and systems are in place, also ensure team is properly trained in these systems and procedures.
Maintain and update the Local Product Document (labelling) in accordance with relevant regulations and SOPs.
Implement systems, processes and procedures relating to regulatory strategy productivity improvements, ensure that these facilitate share information across the relevant lines.
Deliver project /product strategy including label and risk assessment for assigned projects/product.
Ensures business compliance and implementation of and adherence to Regulatory standards.
Develop and enhance relationships with key external agencies, strong partnerships with in-country or cluster markets that give support to facilitate the development and implementation of registration strategies.
Bachelor's Degree (BA/BS) and extensive relevant experience.
Knowledge of the Regional and Global regulatory environment.
Understanding of business and financial environment.
Master's degree (MA/MBA/MS) and relevant extensive experience.
Doctorate (PhD/PharmD/JD) with demonstrable experience.
Thinks strategically with good project management skills.
Ability to manage multiple projects, create and manage project timelines.
Work Location Assignment: Flexible
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. 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. DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Your journey with Pfizer starts here
Regulatory Affairs About Us
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.
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