Regional Regulatory Manager- Pharmaceuticals

Transguard Workforce Solutions is now looking to recruit a Regional Regulatory Manager for a leading client in the Pharmaceutical industry. In this role, you will be accountable for creating the post approval submissions for drug products for country acceptability in terms of content, according to local regulations and requirements for assigned markets. This includes HA query management. The job holder will work in collaboration across the regulatory organisation with stakeholders (such as Product Strategist and in-market Strategists) to deliver efficiencies in regulatory submissions and processes.

In this role, your responsibilities include the following:

• Acting as a single point of contact in the region to populate the relevant parts of the regional Submission Strategy Documents (SSD)
• Serving as primary contact for Heads of RAs in case of any questions on MA transfer and escalating any issues and/or constraints to the regional and global contacts
• Attending regional cross-functional governance forum to represent the regional team.
• Estimating, securing, and managing further resources if needed to support the work across the region (at both regional and local levels)
• Coordinating and managing post approval submissions including Marketing Authorisation Transfer (MAT) for the group of assigned markets
• Developing and managing post approval including MAT plan, strategy, timelines and execution in alignment and partnering with key stakeholders (i.e. PGS, markets, clusters, labeling team, submissions management, CMC, PV, quality) to ensure a submission ready dossier for the assigned market(s).
• Liaising with CMC Product Strategists, ensuring that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets
• Ensuring the submission planning and forecasting tool is utilised to update timelines when necessary, communicate changes to relevant partners
• Ensuring that the submission packages are reviewed against local CMC requirements for consistency and completeness
• Liaising with the manufacturing sites for obtaining supporting documents as needed
• Ensuring the thorough understanding and application of the hub procedures
• Participating in local and regional regulatory initiatives promoting a culture aligned with the organisation's values and which supports compliance, innovation and talent development and retention.
• Assisting in ensuring internal regulatory processes and procedures are well documented. Understanding local regulations and trends for assigned markets, as communicated by the PCO. Managing ad-hoc initiatives or projects, as required.

The ideal candidate will have the following skills and qualifications:

• Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science.
• MSc, MBA or PhD may be an advantage
• Excellent Arabic and English languages
• Experience in regulatory affairs, preferably in human medicines - minimum 5 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 regulatory issues and consistently delivering to time, cost and quality standards.
• Regional regulatory experience including knowledge of MAA submission processes and product lifecycle management processes – minimum 3 years of experience
• 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 Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
• Knowledge and understanding of quality systems, processes, audit and inspection