Senior Manager, CMC Regulatory Strategy

Ipsen Biopharmaceuticals Inc.; Paris; On-site; EUR 100,000 - 140,000; Full time

Job summary

Ipsen Innovation (SAS) seeks a Senior Manager, CMC Regulatory Strategy to oversee CMC regulatory strategy across development to market. You will coordinate with R&D, TechOps, and external partners to ensure alignment of regulatory plans and timely submission of dossiers.

The role focuses on leading CMC regulatory interactions, developing lifecycle strategies, and guiding junior staff in regulatory affairs across global markets.

Qualifications

• Experience leading CMC regulatory strategy for development projects.
• Ability to assemble and oversee CMC regulatory dossiers from development through lifecycle.
• Strong collaboration with R&D, TechOps, and external manufacturing partners.

Responsibilities

• Lead development of CMC regulatory strategy roadmaps for assigned projects.
• Prepare the CMC portion of regulatory dossiers in collaboration with PD/TechOps teams.
• Coordinate with Global Regulatory Affairs leads to integrate CMC strategy into overall regulatory plans.
• Define and execute CMC regulatory plans for R&D and lifecycle management.
• Incorporate regional regulatory needs and emerging requirements into global plans.
• Manage regulatory interactions for site registrations, licences, and filings.

Skills

CMC Regulatory Strategy

Regulatory Planning

Cross-functional collaboration

Dossier preparation

Job description

Title: Senior 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 foster 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

Responsibility for CMC regulatory strategy 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. To manage the CMC Regulatory relationship for their assigned product(s)/projects with Ipsen's GRA LT, manufacturing sites and/or Ipsen's External Manufacturing Organisation (EMO) SMEs and LT, Global Regulatory, CMOs and Alliance partner companies to ensure alignment of strategy. Provide CMC regulatory expertise to R&D & TechOps project teams and lead CMC regulatory interactions for the preparation of submission dossiers And support the development of junior CMC-reg colleagues.

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 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.
• Work closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of all assigned projects.
• Define and execute the CMC regulatory strategy roadmaps for all products in scope (R&D and LCM) ensuring that regulatory requirements are met. Work closely with CMC regulatory senior management to ensure coherence of strategies across projects.
• Ensure regional regulatory specificities and needs are incorporated into the global plans incl. emerging regulations.
• Participate in gap/risk analysis activities as needed, prioritising and planning associated regulatory strategies to address any identified gaps/risks. 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.
• Propose innovative CMC regulatory pathways to accelerate product delivery for patient, as required.
• Communicate with global regulatory lead to propose de-risking through early communications with worldwide health authorities.
• Lead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• 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 pediatric (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.
• Contribute to the development and maintenance of efficient, compliant and robust systems, procedures and processes.
• Manage all Regulatory interactions for Site Registrations, Site Licences, Site master files, annual reports 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/ Technical Operations and Subject Matter Experts (SME) to deliver (