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About the Role

Responsibility for CMC regulatory strategy for assigned projects throughout development phases, from early clinical trials to initial marketing applications, geographical expansion, and life cycle management. Manage CMC regulatory relationships with internal and external stakeholders to ensure strategy alignment. Provide CMC regulatory expertise to R&D & TechOps project teams, lead CMC regulatory interactions for submission dossiers, and support junior colleagues.

Responsibilities

Lead the development of CMC regulatory strategy and overall CMC regulatory roadmaps for assigned projects.
Ensure CMC regulatory risks are identified, assessed, and shared appropriately.
Verify CMC regulatory requirements of targeted countries are met.
Work with CMC regulatory senior management to ensure coherence of strategies across projects.
Lead the preparation of the CMC part of the dossier in collaboration with Pharmaceutical Development and/or Technical Operations teams.
Work closely with Global Regulatory Affairs Therapeutic Area leads to integrate CMC regulatory strategy into the overall regulatory strategy.
Define and execute CMC regulatory strategy roadmaps for all products in scope (R&D and LCM).
Ensure regional regulatory specificities and needs are incorporated into global plans, including emerging regulations.
Participate in gap/risk analysis activities, prioritizing and planning regulatory strategies to address identified gaps/risks.
Propose innovative CMC regulatory pathways to accelerate product delivery.
Communicate with global regulatory leads 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.
Review Target Product Profile (TPP)/Regulatory risk assessment/Regulatory Strategy Document/CCDS/Investigational brochures to ensure aligned regulatory positioning and appropriateness of CMC aspects.
Assess CMC-Regulatory impact of all changes proposed to the allocated product portfolio, providing strategic regulatory advice.
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 CMOs.
Ensure collaboration with teams in Pharmaceutical Development/Technical Operations and Subject Matter Experts (SME) to deliver effective, timely, and compliant CTA (IND, IMPD) and MAA modules 1, 2 & 3 in the correct format “Ready For Submission”.
Write regulatory technical documentation, including updating CTD sections with process and analytical data.
Manage the CMC dossier generation process across all functions, ensuring clarity of roles and accurate data provision.
Manage timely and efficient response to CMC questions from National Health Authorities worldwide.
Prepare and maintain CMC trackers, monitor progress using KPIs, and provide regular updates.
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.
Participate in monitoring the external environment to identify trends and assess potential impact on business.
Actively participate in Industry associations or working groups.
Coach and develop junior resources 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.
Establish and maintain excellent working relationships with Pharm Dev/TechOps teams and the Ipsen regulatory community.
Lead contact with external Alliance partners and CMOs ensuring aligned strategy and optimized communication.
Build effective relationships with global/regional regulators through agencies meetings, scientific advice, and scientific workshops.
Ensure the CMC-Regulatory Strategy Director/Senior Director is provided with accurate and up-to-date CMC-Regulatory strategy for assigned product(s).
Actively contribute to the Regulatory Community life.

Requirements

Proven direct experience in CMC regulatory environment in pharmaceutical industry (approximately 8 - 10 years’ experience).
Proven experience in managing CMC-regulatory activity for products in a worldwide environment.
Proven experience in CMC regulatory on R&D and LCM portfolio.
Experience of Health Authorities interaction.
Proven advanced technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats and publishing support functions.
Proven ability to learn respect in a cross-functional global environment.
Proven understanding of CMC regulatory processes and requirement in US, EU, and export countries particularly JP, China, Brazil, Russia….
Excellent written, verbal and interpersonal communication skills.
Highly organized.
Ability to handle multiple priorities and complex projects in a fast-paced environment.
Strong analytical and problem-solving skills.
Small molecule and biological experience (preferred).
Experience with regulatory management of CMC activities for medical devices and maintenance of associated technical files including interactions with a Notified Body (preferred).

Skills

CMC Regulatory Strategy
CMC Dossier preparation
CMC Regulatory expertise
Regulatory intelligence
Communication
Pharmaceutical Development
Technical Operations
eCTD formats
Analytical skills
Problem-solving skills

Location

US
France
U.K.

Work Type

Hybrid

Experience Level

8-10 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 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.

Equal Opportunity

We are committed to creating a workplace where everyone feels heard, valued, and supported, where we embody “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunity.
When we integrate diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions.
Together, we strive to better understand the communities we serve.
This means we also want to help you do your best when applying for a job with us.
If you need accommodations or assistance during the application process, please inform the recruitment team.
This information will be handled with care and will not affect the outcome of your application.