US Regional Regulatory Strategist - Director
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
We have an exciting opportunity for a Director 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 projects. 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. 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 review and feedback of pending submissions. Due to your expertise, you will be the Regulatory Liaison throughout the product development and lifecycle. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments, etc.
You will be entrusted with developing Pfizer’s strategies for a product and/or portfolio of products and projects.
Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for Pfizer’s patients and healthcare.
How You Will Achieve It
Represent the US for regulatory affairs. Be accountable for ensuring US regional contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects
Provide regional strategic regulatory expertise as regulatory representative to Global Regulatory Strategy Team (GRST).
Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals
Be accountable for timely submissions and approvals and aligning the regulatory strategy with global and business regional needs.
Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s) within designated region
Ensure rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues
Partner with customer groups (e.g. RU/BU, Regional commercial teams) to ensure required regulatory contributions (label, CTA, BLA, sBLA, variations, license renewals, etc) meet business needs and are provided to the project teams, to agreed time and quality standards
Ensure an aligned regional regulatory position is reached and communicated for all key issues for assigned project (s), and that these regulatory positions supporting the regional business are championed and communicated
Ensure rapid reporting of key project/product regulatory milestones and/or issues to the Franchise lead/GRPL and other stakeholders as required
Role can be combined with other Regulatory Role(s) (i.e. regional EM or US lead and/or Global Regulatory Lead for other programs),Project(s) assigned can be in development and/or at post-authorization stage
This is an individual contributor role.
Bachelors degree with 14 years substantial regulatory experience.
Master’s degree with 12 years substantial regulatory experience.
Doctoral/PharmD degree with 9 years in a biological science field
Knowledge of drug development and license maintenance processes, regulatory codes/guidance, and technologies.
Proven experience as a national and/or regional regulatory strategist for at least one product in different therapeutic areas and in different stages of product development. Extensive direct regulatory experience and advanced knowledge of US FDA
Knowledge of systems and electronic technologies used to support regulatory activities.
Excellent communication skills.
Vaccines Experienced preferred
Comfortable with ambiguity and facilitating discussions to explore the best possible solutions.
Strong and collaborative service provider and business partner orientation.
Demonstrated ability to work with or lead a team in a matrix structure.
Proven ability to manage complex regulatory issues.
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.
Other Job Details:
Last Date to Apply for Job: 10/20/21
Additional Location Information: United States - Pennsylvania - Collegeville; United States - New York - New York City; United States - Remote
NO Relocation Package
Eligible for Employee Referral Bonus
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.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer 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.Regulatory Affairs#LI-PFE