The Regulatory CMC Department of our client is looking for a RegulatoryCMC Project Manager to lead and deliver regulatory activities for a small molecule oncology product across global markets working independently as an individual contributor (e.g., for change controls, out of specification regulatory assessment, PQRs, and clinical phase activities) as well as in liaison with the outsourcing team (e.g., variation submissions).

Mission :

To manage and deliver Pharmaceutical Responsibilities activities including :

• End to end management of Change Control procedure, including assessment of regulatory impact analysis and preparation of the regulatory package in collaboration with the outsourcing team.

• Management of Out Of Specification (OOS) for batches under stability;

• Follow up of CMC commitments and variation submissions

• Review of Product Quality Review (PQR) production and Regulatory review of PQR.

To manage and deliver CMC regulatory activities related to progression of clinical programs including :

• Authoring INDs and IMPDs for global markets

• Responding to questions from Health Authorities on regulatory submissions.

• Preparing internal documents supporting QP release of clinical supplies and interfacing with the Quality organization.

• Post IND/IMPD submission management (e.g., change controls, DSURs, IND/IMPD amendments)

• Work with external CMOs

Activities and responsibilities :

• Lead the CMC Regulatory strategy for all pre- and post-approval activities of the asset, providing proactive and timely advice to the technical team.

• Lead and deliver all project management activities to support the CMC pre- and post-approval work of the asset to ensure the necessary regulatory documents are delivered in time and with the adequate quality.

• Liaise with the Local Regulatory Affiliates as needed to develop efficient regulatory strategies to deliver the CMC variation dossiers in line with country requirements and agreed timelines.

• Write, review and compile all regulatory documents in support of each submission on time and in line with global variations guideline.

• Identify rate limiting deliverables and interdependencies across the technical and regulatory aspects for clinical submissions.

• Provide status updates to all stakeholders.

• Management of all documents through the document management system (Documentum-based).

• Any other duties as assigned.

• > 10 year experience in CMC technical roles with at least 5 years working on lifecycle management of small molecule products

• Extensive experience in managing the delivery of pre- and post-approval CMC Regulatory activities for small molecules assets globally.

• Proven track record of effective stakeholder management across the lifecycle activities of assets

• Experience in managing projects within a CMC context. Previous experience on managing projects in a CMC Technical function a plus.

• Experience in change controls, out of specification regulatory assessments, PQRs, clinical phase activities, CMC commitments and variation submissions.

• An understanding of the IND/NDA structure and IMPD/MAA format

• An understanding of drug substance and drug product chemistry, manufacturing and controls (CMC)

• Organized and independent

• Ability to manage multiple activities concomitantly

• Degree in Pharmacy or a relevant science/technical subject

Soft skills :

• Skills in project management, organization, authoring are necessary.

• A good level of autonomy is expected.

• Written and spoken English