JOB TITLE: Regional Regulatory Senior Associate REPORTS TO: Regional Hub Team Lead DIVISION/BUSINESS LINE: Global Product Development (GPD) VERSION DATE: 01-Feb-2019 SUB DIVISION: Global Regulatory Affairs (GRA) DEPARTMENT NAME: Regional Regulatory Hub-AFME LOCATION(S): Egypt 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 knowledge base of country requirements and regulatory environment. Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
Apply regulatory expertise for assigned Products/countries to enable preparation of high-quality documentation and assure compliance with departmental procedures.
Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory, ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
dispatch dossiers to In-Country Regulatory.
Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries.
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.
Maintain Pfizer systems and databases, and applicable Pfizer policies and procedures.
Responsible for ensuring product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
Responsible for ensuring notifications of proposed regulatory changes are communicated to relevant stakeholders in a timely manner.
Responsible for ensuring that comprehensive records of country requirements (communication of requirements for RRM updates) and regulatory status, are maintained.
To regularly follow up progress on regulatory submissions with In-Country Regulatory.
Contributes to the development of filing and approval goals for the region
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 Regional Regulatory Experience : 1-3years
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
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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