Regulatory Affairs Manager at Sanofi

The Regulatory Affairs Manager, Nigeria, is responsible for overall Sanofi Group’s human product-related activities in Regulatory Affairs and liaising with regulatory authorities, government bodies, and other internal/external stakeholders. The incumbent will manage the relationship between Sanofi Nigeria businesses across the group and Global Regulatory Affairs and Nigeria Regulatory Health Agencies.

ESSENTIAL DUTIES:

• Lead all country regulatory affairs activities across the company by establishing and maintaining effective working relationships with Sanofi, ensuring the implementation of regulatory strategies and projects to obtain marketing authorization for new products and approval of pertinent life cycle management initiatives, having as ultimate goal regulatory compliant products to be commercialized according to business strategy.
• Ensures optimal support to key stakeholders to ensure on-time delivery of high-quality dossiers in compliance with Health Authority requirements.
• Ensures optimal expertise on all dossier formats, structure, navigation, and life cycle management globally.
• Ensures close collaboration with the Quality and Process Improvement team to ensure optimal processes and tools are developed and implemented.
• Acts as the primary point of contact for the Regulatory Health Agency of the countries under his responsibility and assures regulatory environment is well understood and considered in country business strategies.
• Lead and develop a high performing regulatory team.

COMPETENCIES:

• Articulate and possess excellent communication skills to cascade, motivate and interact with senior management teams.
• In depth knowledge of Pharma, healthcare, or related industries.
• Excellent knowledge of Pharma Regulatory requirements, process, and procedures with a strong track record of delivery.
• High proficiency in Microsoft Office like Excel, Word, Outlook, and Access.
• Proficient with basic budget management and calculations.
• Able to deliver effective results, meet tight deadlines and targets.
• Strong follow-up skills: ability to organize applicable department timelines and follow up with internal and external customer needs as needed.
• Strong written and oral communication skills, including the ability to present ideas and suggestions clearly and effectively.
• Strong organizational skills: ability to accomplish multiple tasks within the agreed-upon timeframes through effective prioritization of duties and functions in a fast-paced environment.
• Strong track record of building and maintaining solid relationships with both internal and external customers and vendors.
• Self-motivated, able to work both independently to complete tasks and respond to department requests as well as collaborating with others to utilize resources and knowledge in identifying high-quality solutions.

EDUCATION AND EXPERIENCE:

• Bachelor of Pharmacy (B. Pharm.)
• 9+ years’ cognate experience in similar role or organization.