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

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