Regional Regulatory Hub Strategist Associate

Pfizer Inc.

Cairo, Egypt

Job posting number: #7136021 (Ref:pf-4881216)

Posted: March 24, 2023

Application Deadline: Open Until Filled

Job Description

Identifying Job Information

JOB TITLE: Regional Regulatory Hub Strategist Associate

REPORTS TO: Regional Hub Team Lead

DIVISION/BUSINESS LINE: Global Product Development (GPD)

VERSION DATE: 01-Feb-2023

SUB DIVISION: Global Regulatory Sciences

DEPARTMENT NAME:

International Regulatory Sciences & Policies - AFME

LOCATION(S): Egypt

JOB INFORMATION

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

  • Supports regulatory strategies for allocated  Products, and ensure communication/clarity of regulatory timelines and strategy.
  • Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the best in class support for product registration and product life cycle management activities.
  • Responsible for ensuring that regulatory documentation meets relevant regulatory requirements.
  • To apply knowledge and best interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation of health authority marketing authorization dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
  • To ensure business continuity between global/product Strategists and In-Country Regulatory Team.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

  • Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
  • Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
  • Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.

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.

  • Scientific Degree.  A higher degree (Pharmacy, BSc) .
  • Appropriate Regulatory Experience : minimum of 1year regulatory experience
  • Proven ability to consistently deliver to time, cost and quality standards.
  • Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
  • Country/regional knowledge (For AfME only - specifically, MER, NEAR, South Africa, Maghreb)
  • Technical skills with respect to understanding of CMC submissions, BoH Requirements to identify potential risks
  • good communication, negotiation and interpersonal skills
  • Strategic thinking
  • Change agile
  • Analytical thinking
  • Detail- and compliance orientation
  • Big picture thinking

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 AfMe Regional Hub  Team Lead
  • Market regulatory teams
  • Regulatory Strategists (e.g. CMC, global/product strategists)
  • Submissions Management Hub
  • GRRS

RESOURCES MANAGED

Summary of resources managed.

Not applicable

  
 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

#LI-PFE


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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More Info

Job posting number:#7136021 (Ref:pf-4881216)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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