Job Description

Roles & Responsibilities

Role Purpose

• Provide oversight for assigned countries in Africa for the branded Viatris portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post approval submissions.

• To ensure and supervise that regulatory documentation meets relevant regulatory requirements in terms of content, according to local regulations and requirements for assigned markets.

• Accountable for creating submissions for products for the country according to local regulations and requirements for assigned markets. This includes HA query management.

• Ensure dossiers (example: electronic, paper copy, and HA portal) are produced and dispatched to assigned markets according to their defined filing plan and are submission ready.

• Ensures the processes transparency and excellence in execution of regulatory strategies.

• Maintain systems and databases per internal SOPs and policies.

• Collaborate across the regulatory organization with stakeholders (such as Product Strategist and in-market Strategists) to deliver efficiencies in Regulatory submissions and processes.

• Manage the renewals processes for assigned markets.

Key Responsibilities

• Manage post approval submissions for assigned markets.

• Manage post approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. supply chain, markets, clusters, labeling team, publishing hub, CMC) to ensure a submission ready dossier for the assigned market(s).

• Capable of making strategic decision for management of post approval submissions in the cluster she/he manages based on data and/or information from various sources and ensure alignment in understanding within the cluster.

• Oversee complex post approval submissions for the region (e.g technical transfers), from submission planning stage up to approval by BOH.

• Liaise with CMC Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets

• Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners

• Capable of authoring some local submission components in relevant databases

• Ensure submission packages are reviewed against local CMC requirements for consistency and completeness

• Liaise with the manufacturing sites for obtaining supporting documents as needed

• Ensure thorough understanding and application of the Hub procedures

• Participate in local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.

• Assist in ensuring internal regulatory processes and procedures are well documented.

• Understand local regulations and trends for assigned markets and/or cluster, as communicated by the local market regulatory team.

• Participate in cross-region projects and Limited Duration Team for internal processes improvement and ensure implementation consistency within the team.

• Supervise & manage Regional Regulatory Lifecycle Strategists, Managers and/or Contractors when needed.

• Overseeing and managing the renewal submissions to ensure timeous submission and updating of systems.

Supervisory/Management Responsibilities

• Management of the Viatris branded regulatory portfolio for assigned countries from a regional regulatory perspective

• Currently no direct reports, subject to change in future

Position Accountability Scope

• Reports to the Sub- Saharan Africa (SSA) Cluster Regulatory Lead

• Delivery of services to local SSA, Egypt and Morocco market Regulatory Strategists and strategic discussions with global Product Strategists.

• Key stakeholders: SSA and North Africa Supply Chain (Regional and/or market level)

Desired Candidate Profile

Bachelor s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.

MSc, MBA or PhD may be an advantage

Experience in regulatory affairs, preferably in human medicines - minimum 8 years of experience.

Experience in people management will be an advantage

Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.

Proven ability to manage complex regulatory issues and consistently deliver to time, cost and quality standards.

Regional Regulatory experience including knowledge of new submission processes and Product lifecycle management processes.

Demonstrate experience of effective delivery in a matrix environment.

Knowledge of Regional Regulatory environment

Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.

Knowledge of drug development, regulations and guidelines

Leadership and management qualities, including good communication, negotiation, and interpersonal skills

Understanding of pharmaceutical industry, clinical trials and pharmacovigilance

Knowledge and understanding of quality systems, processes, audit and inspection

Capable of making a strategic decision and communicates decision to ensure understanding, alignment and implementation

Ability to influence peers in the organization

Team player

Act independently with less supervision

Analytical thinking

Change agile