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Senior Manager, Global Regulatory Diagnostics Strategy for Oncology

Pfizer · Bothell, United States Of America · Hybrid

$135,100.00  -  $225,100.00

  • Senior
  • Office in Bothell
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Senior Manager, Global Regulatory Diagnostics Strategy for Oncology

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 assisting with diagnostics regulatory tasks. You will play the critical role of providing regulatory strategic direction to teams overseeing clinical development of products and diagnostics.  This will involve interacting with regulatory agencies and diagnostics partners, including negotiations to expedite regulatory approval of trials co-developing medicinal and diagnostic products. Through your expertise, you will be the diagnostic regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing, commercialization, research project teams and government regulatory agencies. Your understanding of regulatory procedures will help support the submission of medicinal and diagnostic product registration, progress reports, supplements, amendments, and periodic reports. These skills will help you evaluate existing internal processes and procedures related to implementation of diagnostic regulations and support other functions to identify gaps and effect change, including modifying or creating processes, to maintain business critical compliance.

As a Senior Manager, you provide guidance to operational teams for managing projects with diagnostics components. Your planning skills will help prepare forecasts for resource requirements and improve products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your dedication that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the division.
  • Develop and maintain tools to ensure tracking of projects, deliverables, and accomplishments.
  • Liaise with and provide input/direction to Clinical Trial Regulatory Operations, Clinical Diagnostics, and other key stakeholder to ensure the associated diagnostic submissions are defined, executed, and the regulatory requirements are met and aligned with the global regulatory strategy of the medicinal product.
  • Work in collaboration with stakeholders across the organization to deliver efficiencies in regulatory submissions and processes.
  • Support development of internal processes and procedures related to implementation of diagnostic regulations.
  • Support other functions to identify gaps and affect change, including modifying existing processes or creating new ones, to maintain business critical compliance.

Qualifications

Must-Have

  • Bachelor's Degree (higher degree preferred)
  • 5+ years of relevant experience
  • Demonstrable experience of effective delivery in a complex matrix environment
  • Regulatory experience to include knowledge of EU IVDR/CTR submission processes and IVDR requirements
  • Regulatory experience including knowledge of New Drug Application (NDA)/Investigational New Drug (IND) submission processes
  • Regulatory experience including knowledge on US device submissions (IDE, 510(k), de Novo, PMA) and CAP/CLIA laboratory requirements
  • In depth knowledge of national/regional regulatory legislation and guidelines
  • Knowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicine
  • Leadership qualities and management skills, team oriented with problem solving skills
  • Strong written and verbal communication and interpersonal skills

Nice-to-Have

  • Master's degree/PhD/PharmD
  • Relevant pharmaceutical experience

*Relocation assistance available if needed

  
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.Relocation support available
Work Location Assignment: Hybrid

The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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 endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Regulatory Affairs