Identifying Job Information

JOB TITLE: Regional Strategist Senior Associate

REPORTS TO: Regional Hub Team Lead

DIVISION/BUSINESS LINE: Global Product Development (GPD)

SUB DIVISION: Global Regulatory Sciences

DEPARTMENT NAME:

International Regulatory Sciences & Policies - AFME

LOCATION(S): Africa Middle East

JOB INFORMATION

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.
• Handle related 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 without-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) may be an advantage but is not essential.
• Appropriate Regulatory Experience: 1-3years’ experience
• Proven ability to manage complex regulatory or drug development issues.
• 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)
• Knowledge of drug development practice, rules, regulations and guidelines.
• 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.

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