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About the Role

Prepare CMC regulatory strategy activities for assigned projects, from early clinical trials to initial marketing applications, geographical expansion, and life cycle management. Manage CMC regulatory relationships with manufacturing sites, external organizations, Global Regulatory, CMOs, and alliance partners to ensure strategy alignment.

Responsibilities

Lead the development of CMC regulatory strategy and overall CMC regulatory roadmaps for assigned projects.
Identify, assess, share, and manage CMC regulatory risks.
Verify CMC regulatory requirements of targeted countries are met.
Ensure coherence of strategies across projects with CMC regulatory senior management.
Lead the preparation of the CMC part of the dossier in collaboration with Pharmaceutical Development and/or Technical Operations teams.
Write regulatory technical documentation, including updating CTD sections with process and analytical data.
Integrate the CMC regulatory strategy with the overall regulatory strategy of assigned projects and products.
Anticipate gaps for planned regulatory submissions, considering emerging regulations and country-specific requirements.
Propose de-risking of 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.
Provide CMC regulatory expertise to project teams.
Propose innovative CMC regulatory pathways to accelerate product delivery.
Review Target Product Profile (TPP)/Regulatory risk assessment/Regulatory Strategy Document/CCDS/Investigational brochures for CMC aspects.
Assess CMC-Regulatory impact of changes to the allocated product portfolio and provide strategic regulatory advice.
Manage Regulatory interactions for Site Registrations, Site Licences, Site master files, and site accreditations.
Ensure collaboration with teams in Pharmaceutical Development, Technical Operations, and Subject Matter Experts (SMEs) to deliver effective, timely, and compliant CTA (IND, IMPD), variations, responses to questions, and MAA modules 1, 2 & 3.
Ensure CMC-Regulatory submissions comply with Ipsen group policies and procedures.
Plan and schedule submissions to align with Technical Operations implementation requirements or clinical supply needs.
Manage submission of annual reports for assigned product(s).
Participate and represent CMC regulatory strategy department in CMC project teams and Global project team.
Proactively provide CMC regulatory expertise to Ipsen functions.
Communicate key regulatory CMC related guidance's to Pharmaceutical Development/technical Operations teams, SMEs, and other stakeholders.
Perform CMC-Regulatory Intelligence activities and ensure related operations are compliant.
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 allocated products.
Identify areas for improvement and implement subsequent actions.
Ensure the CMC-Regulatory Strategy Director/Senior Director is provided with accurate and up-to-date CMC-Regulatory strategy.
Propose and lead continuous improvement process initiatives within the CMC-Regulatory Strategy function.
Serve as CMC-Reg Strategy lead contact with sites, external Alliance partners, and CMOs.
Coach and develop junior resource within the CMC regulatory strategy team.

Requirements

Proven CMC Regulatory experience in managing small molecules and/or biologicals in a worldwide environment (approximately 3-6 years’ experience).
Experience includes 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 and publishing support functions.
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, site registration and licensing.
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.
Experience with regulatory management of CMC activities for medical devices and maintenance of associated technical files including interactions with a Notified Body (preferred).
Experience of Health Authorities interaction (preferred).
Experience with activities in export countries particularly e.g. China, Japan, Brazil (preferred).

Skills

CMC Regulatory Strategy
CMC Dossier preparation
CMC Regulatory expertise
Regulatory Intelligence
Project Management
Stakeholder Management
Technical Writing
Regulatory Writing
eCTD Formats
Pharmaceutical Manufacturing
cGMP Compliance
Critical Thinking
Attention to Detail
Communication Skills

Location

US
France
UK

Work Type

Hybrid

Experience Level

3-6 years

Education Level

Advanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science)

About the Company

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in 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.
Tackles areas of high unmet medical need through research and innovation.
Passionate teams in more than 40 countries focused on what matters and endeavor every day to bring medicines to patients in 88 countries.
Builds a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
Empowers every individual to be their true selves, grow and thrive alongside the company’s success.
Journey towards sustainable growth, creating real impact on patients and society.

Equal Opportunity

Committed to creating a workplace where everyone feels heard, valued, and supported.
Values diverse perspectives and experiences, motivating commitment to inclusion and equal opportunity.
Believes integrating diverse thinking leads to more thoughtful decisions and innovative solutions.
Strives to better understand the communities served.
Provides assistance during the application process if needed, with information treated confidentially and not impacting the application outcome.