Manager CMC Regulatory Strategy

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 endeavour 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!

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, geographical 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 ensuring the CMC regulatory risks are identified, assessed, shared and managed as appropriate; and verifying the CMC regulatory requirements of the targeted countries are met.
• Lead the preparation of the CMC part of the dossier by collaborating closely with Pharmaceutical Development and / or Technical Operations teams.
• Write regulatory technical documentation including updating CTD sections with process and analytical data.
• 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.
• Communicate with global regulatory lead to propose 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.
• Review of the Target Product Profile (TPP)/ Regulatory risk assessment/ Regulatory Strategy Document/ CCDS/ Investigational brochures to ensure single aligned regulatory positioning.
• Assess CMC-Regulatory impact of all changes proposed to the allocated product portfolio.
• Manage all Regulatory interactions for Site Registrations, Site Licences, Site master files and site accreditations with Regulatory Authorities.

• CMC Dossier preparation: Ensure collaboration with teams in Pharmaceutical Development and in Technical Operations, as well as with Subject Matter Experts (SMEs) to deliver effective, timely and compliant CTA (IND, IMPD), variations, responses to questions and MAA modules in the correct “Ready For Submission” format.
• Work effectively with Global Regulatory Affairs (GRA) Therapeutic area, and GRA Regulatory Operations teams to ensure that CMC-Regulatory submissions comply with Ipsen group policies and procedures.
• Manage submission of annual reports for assigned product(s).

• CMC Regulatory expertise & Regulatory intelligence: Participate and represent CMC regulatory strategy department in CMC project teams and Global project team.
• Proactively provide Ipsen functions with CMC regulatory expertise.
• Communicate key regulatory CMC related guidance’s to Pharmaceutical Development/ technical Operations teams, SMEs and other stakeholders within Ipsen.
• Perform CMC-Regulatory Intelligence activities as required.

• 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.

• Communication: Ensure the CMC-Regulatory Strategy Director/Senior Director is provided with accurate and up-to-date CMC-Regulatory strategy for the assigned product(s).
• Assess CMC Regulatory activities and process performance, identify areas for improvement.
• CMC-Reg Strategy lead contact with sites, external Alliance partners and CMOs ensuring aligned strategy and optimised communication.

HOW - Behavioural Competencies Required

• Puts values and ethics at the forefront of everything.
• Anchors Ipsen's purpose, mission and commitments to patients and society.
• Identifies contradictory information/demands/inputs to effectively solve problems.
• Develops and evaluates alternative scenarios and solutions.
• Able to identify what truly matters and ruthlessly focus/ prioritise on making decisions with real impact.
• Methodically assesses, transparently shares, and makes risk-informed decisions.
• Establishes clarity about the goals, accountabilities, timelines, and next steps.
• Displays a commitment to sharing and implementing best practices and committed to excellence in execution.

HOW - Knowledge & Experience

• Knowledge & Experience (essential): Proven CMC Regulatory experience in managing small molecules and/or biologicals in a worldwide environment (approximately 3-6 years’ experience).
• Experience should include registration and clinical development (IND/IMPD) and/or post-approval activities in US and EU and major RoW markets.
• Demonstrated experience in the development and implementation of global CMC-Regulatory strategies for major regulatory submissions.
• Strong project planning skills and ability to develop sound CMC-Regulatory strategy for multiple global changes.
• Proven advanced technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats.
• Sound technical knowledge of the manufacture of pharmaceuticals and appropriate understanding of all regulatory CMC disciplines.
• Strong knowledge of current global regulatory requirements pertaining to the manufacture of pharmaceutical drug substances and drug products.
• Understanding of Pharmaceutical Quality activities and assessment of cGMP compliance.
• Proven experience in both internal and external Stakeholder management.
• Proven experience in handling multiple priorities and complex projects in a fast-paced environment.
• Analytical mindset and excellent attention to detail.
• Excellent critical thinking, written, verbal and interpersonal communication skills.

• Knowledge & Experience (preferred): Experience with regulatory management of CMC activities for medical devices and maintenance of associated technical files.
• Experience of Health Authorities interaction.
• Experience should include activities in export countries particularly e.g. China, Japan, Brazil.

Education / Certifications (essential): Advanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science).

Language(s) (essential): Fluent in English.