Manager CMC Regulatory Strategy

Ipsen Biopharmaceuticals Inc.; Paris; On-site; EUR 120,000 - 160,000; Full time

Job summary

Ipsen Innovation (SAS) in Paris is seeking a Manager CMC Regulatory Strategy to lead CMC regulatory strategy development for projects from early clinical trials through initial marketing applications and lifecycle management. You will drive the preparation of CMC submissions and ensure alignment with regulatory requirements across regions.

Collaborating with Global Regulatory Affairs, Pharmaceutical Development, and external partners, you will identify gaps, coordinate dossiers, and advise on

Responsibilities

• Lead the development of CMC regulatory strategy roadmaps for assigned projects, including lifecycle management and geographic expansion.
• Coordinate the CMC regulatory section of submissions (IND/MAA/CTD modules) with cross-functional teams.
• Prepare regulatory documents and update CTD sections with process and analytical data.
• Collaborate with Global Regulatory Affairs and SMEs to ensure alignment of CMC strategy with overall regulatory strategy.
• Identify and address CMC regulatory gaps for planned submissions and country-specific requirements.
• Interact with site regulatory authorities, alliance partners, and CMOs on regulatory aspects and submissions.

Job description

Title: Manager CMC Regulatory Strategy

Company: Ipsen Innovation (SAS)

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .

Job Description:

WHAT - Summary & Purpose of the Position

Prepare the CMC regulatory strategy activities for the assigned projects throughout the different phases of development from early clinical trials to initial marketing applications, geo-graphical expansion, and life cycle management as assigned by CMC regulatory senior management including leading the preparation of the CMC submission dossiers.

To manage the CMC Regulatory relationship for their assigned product(s)/projects with Ipsen's manufacturing sites and/or Ipsen's External Manufacturing Organisation (EMO), Global Regulatory, CMOs and Alliance partner companies to ensure alignment of strategy.

WHAT - Main Responsibilities & Technical Competencies

CMC Regulatory Strategy:

• Lead the development of CMC regulatory strategy (overall CMC regulatory roadmaps) for the assigned projects (new products in development and/ or commercial product(s) for both lifecycle management and geographical expansion through new MAA registrations) ensuring the CMC reg risks are identified, assessed, shared and managed as appropriate; and verifying the CMC regulatory requirements of the targeted countries are met. Work efficiently with CMC regulatory senior management to ensure coherence of strategies across projects.
• Lead the preparation of the CMC part of the dossier by collaborating closely with Pharmaceutical Development and / or Technical Operations teams, to generate effective CMC regulatory dossiers as per the project timelines.
• 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.
• Work closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of the assigned projects and products.
• Anticipate any gaps for planned regulatory submissions, taking into account emerging regulations and country specific requirements, prioritising and planning associated regulatory strategies to address any identified gaps.
• Communicate with global regulatory lead to propose to de-risking some CMC strategic decisions through early communications and validation with worldwide health authorities.
• Lead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• Provide CMC regulatory expertise to project teams.
• Propose innovative CMC regulatory pathways to accelerate product delivery for patient enrolment in clinical studies, as required.
• Review of the Target Product Profile (TPP)/ Regulatory risk assessment/ Regulatory Strategy Document/ CCDS/ / Investigational brochures to ensure single aligned regulatory positioning and appropriateness of any CMC aspects, including paediatric (presentation, formulation, excipients) and ROW considerations, as required.
• Assess CMC-Regulatory impact of all changes proposed to the allocated product portfolio, providing strategic regulatory advice and clearly communicating any Regulatory impact and CMC-Regulatory supporting data requirements for subsequent variations/ amendments.
• Manage all Regulatory interactions for Site Registrations, Site Licences, Site master files s and site accreditations with Regulatory Authorities, Alliance partners and CMO's for assigned product(s) as applicable.

CMC Dossier preparation:

• Ensure collaboration with teams in Pharmaceutical Development and in Technical Operations, as well as with Subject Matter Experts (SMEs) to deliver (coordination, authoring and review) effective, timely and compliant CTA (IND, IMPD), variations, responses to question and MAA modules 1, 2 & 3 in the correct "Ready For Submission" format for assigned products, in compliance with eCTD requirement.
• Work effectively with Global Regulatory Affairs (GRA) Therapeutic area, and GRA Regulatory Operations teams t