Regional Regulatory Lead

SUMMARY:
Leading Pharmaceutical Company on East Rand seeking Regional Regulatory Lead to join their team

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

Minimum Requirements

• 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

• Manage post approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. supply chain, markets, clusters, labelling 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.

• 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

NB! This job is now closed. You can apply for other jobs by uploading your CV.