Senior Manager, CMC Technical writing

Job Title:Senior Manager, CMC Technical writing

Division / Function: Global Regulatory Affairs (GRA)

Manager (Name, Job Title): Director/ Sr Director, CMC Regulatory

Location: Balard/ Dublin/ Paddington

Summary / purpose of the position

The Senior manager, CMC-technical writing will have responsibility for the CMC (Chemistry Manufacturing and Control) regulatory strategy for authoring submissions from clinical phase to global registration and associated lifecycle management of Ipsen’s assets as assigned by the Director/Sr Director CMC-Regulatory. He/she will manage the CMC dossier authoring process and the CMC Regulatory relationship for his/her assigned product(s) with the different stakeholders from pharmaceutical development, Ipsen’s manufacturing sites and/or Ipsen’s External Manufacturing Organisation (EMO), Global Regulatory, Contract Manufacturing Organisations (CMOs) and Alliance partner companies to ensure alignment of strategy and delivery of the written dossier as per planning.

Main responsibilities / job expectations

• Lead the development of the CMC regulatory strategy roadmaps to author the CMC sections for assigned projects at the different stage of development including gap analysis activities (as needed), prioritising and planning associated regulatory strategies for authoring to address any identified gaps and manage corresponding mitigations.
• Manage the Authoring and editing of CMC sections of regulatory filings for small molecule compounds in clinical development stages, including IND/IMPDs, supplements, and amendments.
• Manage the Authoring and editing of CMC sections of regulatory filings for small molecule compounds for submissions in a Global environment, including NDA/MAA or equivalent, supplements/ variations.
• Ensure delivering (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 assigned products in compliance with eCTD requirement and Ipsen Group Regulatory Affairs Dossier Management rules as required.
• Collaborate with technical subject matter experts (analytical, drug substance, and drug product development) to review, interpret data, and author from technical reports sections of the registration files, to generate effective CMC regulatory dossiers aligned with defined roadmaps to optimize time to market of new products and improve drug product through life cycle management.
• Lead authoring of CMC regulatory sections of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• Manage timely and efficiently the authoring of Response to CMC questions from National Health Authorities worldwide with support from SMEs as necessary, in order to meet expected submission approval timelines.
• Summarize scientific information from development/validation reports relevant for regulatory submissions.
• Prepare and maintain the necessary CMC writing trackers, monitor progress and provide regular updates to the team.
• Ensure emerging regulations and country specific requirement are incorporated into the global authoring plans.
• Proactively provide Ipsen functions (e.g. Pharm Dev, TechOps SMEs, GRA, Global project teams, etc) with CMC regulatory expertise impacting authoring of the CMC dossier.

• Communicate key regulatory CMC related guidance’s to Pharmaceutical Development teams, SMEs and other stakeholders within Ipsen.
• Monitor and report on CMC Regulatory authoring activities and process performance for the allocated products; identify areas for improvement, implement and monitor subsequent actions.
• Establish and maintain an excellent working relationship with Pharm Dev 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.
• Work effectively with Global Regulatory Affairs (GRA) Therapeutic area teams, and GRA Regulatory Operations teams to ensure that CMC-Regulatory dossiers are compliant with Ipsen group policies and procedures and are planned and scheduled appropriately to align with Technical Operations implementation requirements while ensuring adequate time for review, approval and publishing tasks.
• Lead the authoring of the CMC section of US Annual Reports for assigned product(s) and liaise with relevant subject matter experts as necessary ensuring on-time completion through efficient coordination with GRA US.

Knowledge, abilities & experience

Education / Certifications:

• Advanced degree (Masters or PhD) in scientific discipline (such as Pharmaceutical/ Medical/ biological/ Chemical Science)

Experience:

• At least 8 years work experience in multinational Life Science companies with at least 5 years relevant CMC Regulatory experience of small molecules is essential.
• Experience should include clinical development (IND/IMPD), registration and post-approval activities in US, EU and major Intercontinental markets e.g. China, Japan.
• Demonstrated experience in the development and implementation of global CMC-Regulatory strategies for major regulatory submissions.

Languages:

• Fluent English