Job Description

Job Summary The Regulatory Affairs Manager will lead, manage and provide strategic direction and oversight to his / her direct manager and to the Cluster Lead and above regulatory teams to develop and execute regulatory strategies and plans for the countries. Responsibilities Provide strategic direction & manage portfolio across ELI distributor managed markets, within Portfolio in his/her capacity. Accountable for all strategic regulatory activities for the portfolio within his/her capacity including pre- and post-authorisation product lifecycle activities and delivery of operational regulatory activities in partnership with above-country operational hubs. Deliver country strategic priorities and operational plans to budget and support delivery of regional regulatory objectives. Provide regulatory guidance/input into global and regional product development and regulatory strategies. To support portfolio within their capacity. Develop strong partnerships within the country (e.g. Category Leads, Medical, Marketing, Supply Chain), and above-country functions (e.g. GCMC, WSR Regulatory Hubs) and above-country WSR Therapeutic Area and Regional Teams to facilitate the development and implementation of regulatory strategies to expedite the registration of new products, line extensions and life-cycle optimization. Ensure internal regulatory processes and procedures are well documented and support compliant regulatory activities in alignment with Regulatory excellence team. Assure local licenses in country(ies) under responsibility are maintained (e.g. Marketing Authorizations) in compliance with local regulations and following corporate policies, regulatory processes, SOPs and keeping the systems updated (e.g. CMC change control, product labelling, etc.) Drive alignment and co-ordination of standards, by identifying and implementing processes, best practices and enabling the efficient and effective alignment of resources, skills and expertise in support of the business Driving timely action toward the objective and desired results. Easily identify the areas that need the highest focus and contribution Promote good practices and share knowledge across all geographical reaches and within network in order to benefit from organizational learning and trouble-shoot technical issues on a range of system applications (process root cause analysis) Proactively anticipate new or unexpected situations and potential shortcomings and finding areas of opportunity for improvement Understand local regulations and developing trends in the local regulatory environment of the countries under responsibility and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making. Influence on new legislation initiatives that could impact the business.

QUALIFICATIONS / SKILLS Qualifications : Pharmacist by education Min 2 years of experience in pharmaceutical industry from a regulatory affairs perspective Knowledge pharmaceutical legislation relevant guidelines, procedures and requirements in Morocco and ELI region Fluent in oral and written Arabic, French and English

Skills: Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance. Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources. Strong initiation and organizational skills IT skills

ORGANIZATIONAL RELATIONSHIPS

Report to the Regulatory Sciences Cluster Lead. Interaction with cross-functional department team members and Manager levels will be frequent.

Interaction with Health Authorities will be frequent.

Work Location Assignment: Flexible Type of Contract: Temporary Contract of 1 year (CDD)

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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