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Senior Director - Global Head, Regulatory Data and Conformance Management

Employer
Pfizer
Location
Remote, Remote, United States; Collegeville, Pennsylvania, United States;
Salary
Competitive
Closing date
Jun 5, 2023
JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

Leads strategic direction and oversees day to day operations of Pfizer's global portfolio of Regulatory Data and Conformance Management activities within Global Regulatory Sciences - Global Regulatory Operations (GRA-GRO) group. RDCM have responsibility for Clinical & Commercial Regulatory milestone management throughout Product & Registration Lifecycles, e.g., commercial and investigational activities for Global Regulatory & CMC triggers. The RDCM global organization supports a stakeholder network of over 2000 people, managing regulatory (including CMC) milestones and maintaining compliance with applicable regulatory obligations while working to tight, business-critical, deadlines within a highly regulated environment. Holds single point of accountability for overall management of the CRDM global procedures, service and solution which enable quality deliverables whilst establishing longer term strategies for optimization and influencing best RIM practices across stakeholders.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.
  • Oversight and management of people, financial and technical resources associated with RDCM, including, but not limited to, global clusters in USA, UK, Colombia, Poland and India to meet the global needs for U.S.A. / EU / LATAM / CA / AfMe / EME / ROW / Asia market demand.
  • Leads Team supporting Commercial and Clinical Conformance updates in PDM for all Pfizer product submissions with a CMC contribution to ensure visibility of registered content to enable product release and CMC Regulatory Change Management
  • Data management of regulatory milestone information associated with the end to end Regulatory continuum
  • Leads business performance including successful, compliant, on time delivery of CDM responsibilities in support of regulatory milestone management of commercial and investigational activities for submissions and decisions across all Pfizer markets.
  • Drives internal and influences external process and standard transformations to ensure milestone management of key regulatory events.
  • Drive quality and efficiency through application of digital opportunities to the CDM processes.


The incumbent is expected to be a technical and functional expert in Regulatory Information Management practices as well as skilled in developing centralized hub support architecture supporting a globally diverse stakeholder community across US, EU and ROW. Overall this position is accountable for Pfizer's RDCM standards and training materials and at all times will have comprehensive and detailed oversight of quality control for all ~ 160 RDC M resources, over 2000 stakeholders globally associated with management of milestone data for regulatory management activities.

Key Accountabilities:
  • Drives risk-based innovations including digital opportunities to increase quality and efficiency through automation/AI
  • Ensure maintenance of the corporate change and dossier management system (PDM) regarding the status of regulatory submissions with global health authorities as per internal SOPs and policies for Pfizer products within scope of the CMC Change Management process.
  • Lead and drive strategic direction of Regulatory Data and Conformance Management capabilities
  • Accountable for financial and resource management in line with portfolio demand
  • Harnesses external forums & networks to influence best practice or transformational opportunities
  • Establishes change management frameworks to influence large (2000+) network of stakeholders
  • Advocate for Regulatory Information mastery, influencing Pfizer adoption of best practice
  • Establishes innovative culture encouraging acceptable risk taking towards optimization
  • Mastery of complex talent management, career path and retention and future leader development strategies for this unique function in Pfizer
  • Continually scan geographic landscape for new cluster location opportunities considering regulatory maturity, talent pipeline, market forces, politics, language capabilities etc.
  • Overall accountability for global RDCM processes, standards and quality
  • Oversight of all CRDM functions globally, ensuring streamlined product/data management
  • Coordinates with remote/local peers to ensure compliance with local and global regulatory requirements
  • Ensures that assigned projects/technologies relating to evolution of CRDM delivery processes and deliverables are carried out according to timelines
  • Support PLMDS LT in load balancing and resources for the respective global sites (e.g., UK, US, India, Poland, Colombia)
  • Collaborates with PLMDS leadership for the identification of vendor resource requirements and resource allocation for weekly and monthly forecasts
  • Accountable for FTE/ vendor/Contractor training and quality requirements
  • Establish effective and open communication with all relevant stakeholders to ensure appropriate staffing and coverage
  • Pro-actively identify operational issues or trends and collaborate with ST, GRS-GRO leadership and vendor to develop process solutions including corrective action and continuous improvement activities when needed
  • In collaboration with RIM, drive implementation of technological solutions to the RDCM process across all geographies
  • Understand and interpret requirements for global RDCM model as defined by FDA, EMA, MHLW, ICH and national markets
  • Escalate unresolved or major global/regional/local issues impacting Pfizer business to GRS-GRO leadership, including recommendation to pursue service level remedies where appropriate
  • Oversee the coordination of global/regional/local BT application access according to Pfizer SOPs
  • Support and review vendor and global Pfizer business continuity plans
  • Responsible for professional development through mentorship and motivation


QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
  • Understanding of the concepts around regulatory affairs and significant knowledge of submissions processes in support of RDCM.
  • A strong understanding of technical requirements as defined by FDA, EMA, MHLW, ICH, and regional markets in support of establishing clear RDCM local vs global standards
  • Influencing & change agent skills that can exhibit regulatory knowledge and understanding, technical competence, sound judgment, and a professional demeanor.
  • Articulate with strong analytical and interpersonal skills
  • Skilled in managing significant scale of portfolio of work, and load balance across different locations/geographies/time zones
  • Ability to embrace new technologies and process and drive implementation remotely
  • Knowledge of pharmaceutical business, including drug development and regulatory aspects
  • Proven aptitude in project management and process redesign
  • Proven experience in managing both people and managers of people
  • Expertise in both data management and data analysis
  • Master's or Undergraduate degree/ with significant Regulatory/Biopharmaceutical experience
  • Demonstrated knowledge of Regulatory submissions, code, guidance and specifications.
  • Demonstrated ability to communicate complex information and analyses to a variety of audiences in both verbal and written format.
  • Demonstrated Technology aptitude
  • Project Management skills: Mastery of processes, tools , techniques and change management for planning and monitoring projects to established deadlines. Familiarity with pharmaceutical organizational structures, systems, and culture.


ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.
  • Reports to: Global Head, PLMDS
  • Establishes change management frameworks to influence large (2000+) network of stakeholders.


RESOURCES MANAGED

Summary of resources managed.
  • CDM Cluster Leads, Global CDM Process Excellence, CDM and RCM-CH Data Associates (Jr./Sr.). Overall accountability for 160+ resources and line budget


#LI-Remote

The annual base salary for this position ranges from $232,300.00 to $387,200.00. In addition, this position offers an annual bonus with a target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

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.

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