We have an exciting opportunity for a Senior Manager to join our vaccines Global Regulatory Affairs team as the US Regional Regulatory Strategist (RRS). This is an excellent opportunity to join a growing and dynamic team and be in charge of various programs. We are looking for candidates with a dynamic and agile profile with a scientific background, and strong regulatory experience. The candidate should be passionate for vaccines, willing to learn and advance in their career.
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.
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. 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 medicines and vaccines.
What You Will Achieve
You will represent Pfizer as an Approval Liaison in the regulatory affairs team. 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. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the
division. You will:
Report to Global Regulatory Affairs vaccine Franchise Lead
Serve as US Regulatory Lead on assigned programs in the vaccine therapeutic area, providing regulatory input to teams.
Work with teams to develop and deliver regulatory strategies for Phase 1 through Phase 4 development stages.
Manage regulatory aspects of programs, including the preparation and submission of correspondences and applications to regulatory agencies.
Understand regulatory environment and communicate priorities to stakeholders.
It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Be accountable for leading or contributing to the preparation of Global Regulatory Strategies and implementation plans (core labels, risk registers, global filing plans) for assigned projects.
Develop regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management.
Partner with project teams and other customers (e.g. Vaccine Research Unit, Vaccine Business Unit, Regional Commercial Teams) to ensure regulatory contributions (Global Regulatory Strategies, labels, INDs, BLA, sBLA, etc) meet business needs and are provided within agreed time, cost and quality standards.
Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the business are championed and communicated.
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 (labeling) 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.
Ensure rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.
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.
Role can be combined with other Regulatory Role(s) (i.e. regional EM or EU lead). Project(s) assigned can be in development and/or at post-authorization stage.
Qualifications and Experience
Bachelor's Degree (BA/BS) and 9+ years of experience. MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.
Knowledge of the Regional and Global regulatory environment. Work experience with demonstrable contribution in Regulatory, including knowledge of IND/CTAs, BLA/MAA and other submission processes. Global experience desirable.
Knowledge of drug development practice, rules, regulations and guidelines. Prior vaccine development experience preferred.
Understanding of business and financial environment.
Strategic thinking with good project management skills. Ability to manage regulatory issues.
Ability to manage multiple projects, create and manage project timelines. Proven ability to consistently deliver within time, cost and quality standards.
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. Pfizer's open-door policy is an integrated part of our culture across all levels of seniority.
We offer possibilities for working from home and flexible working hours.
Competitive salaries and benefit packages.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.