Pfizer

Senior Manager, GSM

Employer
Pfizer
Location
La Jolla, California; Lake Forest, Illinois; New York City, New York; Groton, Connecticut
Salary
Competitive
Posted
April 30 2021
Ref
4812715
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager
ROLE SUMMARY

Provides an interface to Regulatory partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory submissions to regional partners and selected Health Authorities.

The Global Submission Manager (GSM) is accountable for working with contributing business lines to lead operational submissions execution for designated major assets. They may operate as regulatory operational Subject Matter Expert for a Major asset and drive submission teams towards the timely delivery of globally compliant submission-ready components.

The GSM may be assigned as a Hub Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected geography.

ROLE RESPONSIBILITIES
  • Drives global submission management activities for their assigned products. Partners

with product teams and/or third-party partners, with responsibility for representation and
management of required regulatory activities, standards and deliverables associated with
major submission development and execution for designated products and/or
geographies.
  • Key participant and member of development teams and relevant endgame committees, to

advocate realistic deliverable timelines, understand project strategy, and assess
associated impact and present status of global submission delivery activities.
  • Matrix manages global team efforts to ensure high quality components and submissions

that are compliant with industry, agency and format guidelines, regulatory strategies,
policies, and timelines.
  • Coordinates submission production and assists with definition, development, and

implementation of global submissions policies and technologies to meet evolving
business needs.
  • Escalates, informs, and resolves any issues that may impact submission builds or the

logistics of global submission delivery to regional partners or Health Authorities.
  • Serves as a major source of innovative ideas seeking and developing efficiencies and

effectiveness within the Submissions process by collaboration with key customer and
supplier groups and business partners,
  • Promotes professional development through mentoring and motivating colleagues.

  • Engages Submission leaders, business suppliers and other key regional representatives to

define and agree on process, activities and schedule for the transfer of re-useable
submission documentation for multiple regional filings.
  • Drives connectivity and implements refinements in the Emerging Markets partner model

through collaboration with peers
  • Promotes the use of Document Management and Archival systems and standard

document authoring and publishing processes, partnering with supplier groups as
  • necessary in order to produce timely delivery of submission/archive ready components.

  • Functions as a change agent that can exhibit regulatory knowledge and awareness,

technical competence, sound judgment and a professional demeanor
  • Operates as single BU Liaison point of contact for Regional Regulatory Leads and

designated major assets.
  • Leads the interpretation of regulatory guidelines to produce business requirements and

ensure that those requirements are implemented where appropriate at local level.
  • Manages own time to meet objectives; forecasts and plans resource requirements

(people, financial and technology) for projects across Department
  • Provides guidance to and leads moderately complex submission and process

improvement projects, making decisions independently
  • Considered a technical resource within the group

  • Drives communication and proposes refinements in the Emerging Markets partner

model through collaboration with stakeholders and regulatory leaders
  • Leads Lessons Learned sessions and implements change in partnership with Dossier

Excellence Team
  • Serves as Pfizer SM representative with Health Authority meetings, Industry

discussions/ initiatives
  • Contributes to changes in policies and strategies to meet evolving business needs

  • Functions as a change agent that can exhibit regulatory knowledge and awareness,

technical competence, sound judgment and a professional demeanor
  • Self-initiates assignments, developing innovative ideas to resolve complex problems and

leading the execution of projects
  • Operates as delegate for SM leadership as required.


QUALIFICATIONS

Bachelor's Degree with 9+ years, Master's Degree with 7+ years, or PhD/equivalent with 4+ years of relevant experience

B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable)
Proven technical aptitude and ability to quickly learn and use new software, regulations and
quality standards
Multi-lingual skills desirable.
Familiarity with pharmaceutical organizational structures, systems, and culture is preferred

Technical Skill Requirements
- Proven aptitude in leadership, problem solving and logistics
-Ability to work on multiple highly complex projects simultaneously.
-Demonstrated attention to detail.
-Strong knowledge of the drug development process, regulatory affairs, and submissions
management.
-In-depth understanding of systems and electronic technologies used to support submission and
planning activities, as well as demonstrated experiences in process development and new
technology implementation.
- Ability to operate seamlessly and influence direct and indirect reports, as well as across
organizations.

-Significant knowledge of the drug development process, Regulatory Affairs and submissions

management.
- Demonstrated understanding of regional and national regulator filing guidelines and dossier
requirements.
- Demonstrated ability to lead and deliver through others in a matrix model
-Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances
- Robust organizational management skills
- Advanced knowledge of the processes, systems and regulatory guidance and a detailed
understanding/knowledge of principles and concepts of other disciplines
- Proven ability to embrace new technologies and processes and drive their implementation

#LI-PFE

Other Job Details

Last Day to Apply: May 13th 2021

Eligible for Employee Referral Bonus

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.

Regulatory Affairs

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