Oversee and direct compliance activities associated with the Regulatory process and associated tool(s), ensuring that Pfizer maintains compliance with both internal procedures and applicable regulations (e.g., Article 57, IDMP).
Through use of governance structures, quality controls and key performance indicators, oversee monitoring, reporting, quality assurance and inspection readiness of regulatory processes and information such as product and license data, ensuring alignment with GxP.
Represent WSR, PEH GRA, WRO with internal and external audits and inspections, and utilization of trends in findings to drive improvements.
Identify, understand, measure, communicate, and mitigate compliance risks related to Regulatory Product and License process, information and systems spanning regulatory affairs.
Sponsor and contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps, mitigate risks and improve compliance. Promote efficiencies within and consistencies between these processes, across all participating stakeholders.
Working as a matrix with global delivery teams to govern the quality, delivery and compliance associated with regulatory processes, and product and license information.
Overall accountability for ensuring compliance of in scope regulatory processes.
Sponsorship and leadership of cross-disciplinary governance forums.
May serve as representative on Project Teams and/or Pfizer project governance bodies & steering committees to achieve consensus for specific strategies.
Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum processes in support of products throughout the development and commercial lifecycle of the drug.
Govern implementation of global policies and strategies to meet evolving business needs
Govern implementation of technological solutions to the varying aspects of regulatory compliance.
Demonstrated ability to effectively lead cross-functional teams and to autonomously influence business decisions where direct reporting line relationships do not exist.
Collaborate with peers at other pharmaceuticals and global regulatory authorities as appropriate to lead direction and development of regulations and guidance.
Support peers in process ownership for the regulatory processes, monitoring adherence and ongoing process adjustments as needed.
Ensure appropriate processes exist for ongoing assessment and maintenance of procedures and processes to identify procedural and compliance gaps; establish and monitor remediation plans
Oversee identification and assignment of necessary training programs, establishing and monitoring adherence to curricula
Lead and/or sponsor cross-functional and strategic initiatives, novel concepts and solutions to enhance and improve conformance.
Bachelor's degree required in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.
10+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 8+ years pharmaceutical regulatory experience.
6+ years' matrix leadership, including experience providing guidance and coaching for others globally, managing resource capacity and prioritizing workload.
Experienced in exercising independence in judgment and decision-making principles to influence regulatory & business strategy and process, guiding complex projects with broad impact and balancing risk with organizational flexibility & business needs
Experience leading collaborations within & across divisions, working with other scientific & technical leaders to drive projects and implement business initiatives.
Capable of developing & advocating regulatory and quality policies.
Mature demeanor to effectively collaborate & guide under accelerated timelines & volatile business pressure not inclined toward reactionary or hasty judgment.
High level of knowledge of the drug development process and significant experience operating within GxPs.
Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
Knowledge of the Regulatory business as it relates to drug development and license maintenance
Strong Experience with regulatory data and submissions, process development and GxP
Strong understanding of Regulatory environment including CTD content/structure.
Detailed Understanding of accurate regulatory product and license information Data management throughout lifecycle and its impact on downstream processes
Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for assigned projects, mentor and share experience with colleagues.
Demonstrated sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory discipline and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.
Excellent English writing and oral presentation skills is mandatory.
Computer literacy with Microsoft Office Suite and Documentum-based applications
Ability to influence without authority
Master's degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.
Experience engaging in the external regulatory & pharmaceutical environment is preferred.
Knowledge of partnering organizations and systems is desired.
Lean and/or SixSigma experience helpful.
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.
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.
Other Job Details:
Last Date to Apply for Job: September 28, 2018
Additional Location Information: New York, NY; Peapack, NJ; Collegeville, PA; Lake Forest, IL; Groton, CT.
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.