Senior Manager, CMC Regulatory Strategy

CMC Dossier preparation

• Ensure collaboration with teams in Pharmaceutical Development/ Technical Operations and Subject Matter Experts (SME) to deliver (coordination, authoring and review) effective, timely and compliant CTA (IND, IMPD) and MAA modules 1, 2 & 3 in the correct format “Ready For Submission” for Ipsen products portfolio in compliance with eCTD requirement and Ipsen Group Regulatory Affairs Dossier Management rules as required.
• Write regulatory technical documentation including updating CTD sections with process and analytical data extracting information from reports, batch records, analytical procedures and quality events as appropriate.

Responsible for the CMC dossier generation process across all functions: ensure the role of each function involved in the generation of the CMC dossier is clear and will provide accurate data with the correct level of detail in compliance with regulatory requirement.

Manage timely and efficiently the Response to CMC questions from National Health Authorities worldwide with support from Pharmaceutical Development/ technical Operations teams and Subject Matter Experts (SMEs) as necessary to reach submission approval.

Prepare and maintain the necessary CMC trackers, monitor progress using KPIs and provide regular updates to the team.

CMC Regulatory expertise & Regulatory intelligence

• Participate and represent CMC regulatory strategy department in CMC project teams and Global project team, as necessary, for the assigned projects.
• Proactively provide Ipsen functions (e.g. Pharm Dev, TechOps, SMEs, GRA, Global project teams, etc) with CMC regulatory expertise.
• Communicate key regulatory CMC related guidance’s to Pharmaceutical Development/ technical Operations teams, SMEs and other stakeholders within Ipsen.
• Participate in the monitoring of the external environment to identify trends and assess potential impact on business and communicate this information to stakeholders.
• Actively participate in Industry associations or working groups and ensure company’s interests are taken into account.

Resources and performance

• Coach and develop junior resource within the regulatory strategic CMC Group.
• Lead and manage assigned projects and associated communication and reporting.
• Monitor and report on CMC Regulatory activities and process performance for the allocated products; identify areas for improvement, implement and monitor subsequent actions.

Communication

• Establish and maintain an excellent working relationship with Pharm Dev/ TechOps teams and the Ipsen regulatory community, in particular with Ipsen Global Regulatory Affairs Therapeutic Area Leads, European and intercontinental leads, Regulatory Operations Publishers and Ipsen affiliates/partners to ensure efficient coordination of regulatory submissions.
• Lead contact with external Alliance partners and CMOs ensuring aligned strategy and optimised communication.
• Build effective relationships with global/regional regulators through agencies meetings, scientific advice and scientific workshops to ease validation on Ipsen strategy.
• Ensure the CMC-Regulatory Strategy Director/Senior Director, is provided with accurate and up-to-date CMC-Regulatory strategy for the assigned product(s).
• Actively contribute to the Regulatory Community life.