Director, US Regional Regulatory Strategist
Job Description
We have an exciting opportunity for a Director to join our vaccines Global Regulatory Science team as a 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 act as direct liaison with regulatory authorities ensuring assigned projects are delivered timely and successfully.
ROLE SUMMARY
• Represent the US for regulatory science
• 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
• 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.
ROLE RESPONSIBILITIES
• Accountable for ensuring US regional contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects
• Provides regulatory expertise and leadership for the project/product.
• Ensures regulatory contributions achieve the strategic objectives, achieve agreed standards, maximizing overall project delivery time
• Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.
• Partners with customer groups (e.g. RU/BU, Regional commercial teams) to ensure required regulatory contributions (label, CTA, MAA/IRD, variations, license renewals, etc) meet business needs and are provided to the project teams, to agreed time and quality standards
• Ensures 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
• Ensures business compliance and implementation of and adherence to regulatory standards
• Ensures rapid reporting of key project/product regulatory milestones and/or issues to the Franchise lead/GRPL and other stakeholders as required.
• Develop and maintains, directly or indirectly, constructive working relationships with Health Authority contacts in the assigned region
QUALIFICATIONS
• Scientific Degree. BS is required. MS, PharmD or PhD preferred. Equivalent workplace experience can be considered.
• 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
• Advanced knowledge of US FDA
• Vaccines Experienced preferred
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel may be required
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer 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 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. This position requires permanent work authorization in the United States.
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.
