Senior Pharmaceuticals Regulatory Affairs Manager - Alexandria

• Caduceus Lane is hiring a Senior Pharmaceuticals Regulatory Affairs Manager, who will be responsible for developing regional regulatory strategies. The Senior Pharmaceuticals Regulatory Affairs Manager is a critical strategic role and will report directly to the Managing Director.
• Caduceus Lane is seeking initiative-taking, self-motivated candidates, with proven experience and unmatched career ambition to be a part of Caduceus Lane’s ongoing growth.

Key Responsibilities

• Representing the company in interactions with external organizations; including the formal authorities, sponsors, and other organizations, in addition to serving as a primary contact during all pre-market activities and reviewing and approving regulatory submissions

• Working cross-functionally with key functions to provide ongoing developmental opportunities and ensure compliance

• Developing, managing, and implementing strategies and timelines for regulatory registration activities

• Keeping abreast of changes in pharmaceutical regulations and legislation, reporting metrics, and providing advice and information when needed

• Developing and maintaining a good relationship with the internal and external stakeholders

• Providing an expert review of products submissions, design dossiers, technical files, post-market submissions, and other regulatory documents

• Developing strategic infrastructure for the Regulatory Affair Department, as well as the hierarchical framework and departmental SOPs

• Identifying pharmaceuticals manufacturing sites, managing agreements, and activating brand manufacturing (Europe)

• Creating logistics Master Plan, building pipelines, and managing product lines and molecule acquisition assessment, in addition to negotiating partnership and managing contracts (Europe)
• Structuring company’s strategic portfolio and formulating integrated market access strategies in collaboration with internal business partners