Job Title: Director CMC Regulatory Processes and Systems
Division / Function: Global Regulatory Affairs GRA
Manager (Name, Job Title): Head CMC regulatory strategy
Location : Paris or London (Paddington)
Summary / purpose of the position
Develop and automatize processes, systems and tools to improve quality, performance and efficiency within the regulatory CMC organization, with methodological support, leveraging data as a strategic asset to facilitate data driven decision making. Identify strategic improvements and value creation and implement best solutions tools and techniques.
Foster cultural change by sharing best practices and solutions, knowledge of tools and processes for continuous improvement and as such facilitate interfaces with stakeholders for the purpose of maximizing regulatory CMC business from early development to life cycle management, facilitating submissions and approvals in a timely and high-quality manner.
Main responsibilities / job expectations
- Responsible for mapping processes, systems and tools used for regulatory CMC activities from early development to life cycle management for all products.
- Deliver and implement end to end robust simplified processes, in collaboration with all stakeholders, to reduce barriers to execution, define clear roles and responsibilities. Ensure this is documented through either standard guides or procedures.
- Collaborate with regulatory Operation director system and identify opportunities to enhance Veeva RIM (eDMS) capabilities, usage to improve and streamline Regulatory CMC processes.
- Develop robust reporting mechanisms to communicate compliance status, risks, and system performance to senior management and stakeholders.
- Utilise data analytics and reporting tools to track compliance metrics and generate actionable insights from our data.
- Ensure processes, systems and corresponding metrics are in place to:
- identify CMC source documents required for regulatory filings in collaboration with stakeholders (pharm Dev, MS&T, LRA)
- monitor deliverables (protocols, reports, section of Module3 as needed) from subject matter experts (SME) from Pharm Dev and MS&T
- monitor expected and actual timelines for dossier readiness from regulatory CMC
- monitor expected and actual timelines for submissions, approvals from Local Regulatory Affairs (LRA)
- monitor new launches and implementations for changes in collaboration with TechOps contributors.
- Lead and drive the development and implementation of a sustainable improvement systems and tools that enables regulatory CMC to continuously improve the efficiency and effectiveness as the environment and Ipsen strategies evolve. Contribute to the establishment of a culture of continuous improvement mindset.
- Establish processes and tools to initiate, plan, execute, monitor, and report on our activities for clinical trials applications, marketing applications and post approval activities.
- Initiate and maintain the regulatory CMC strategic plan across the different assets, identify team synergies and/or conflicts early and propose solutions in agreement with stakeholders.
- Create visibility and reporting on our team activities.
- Ensure a platform is built and maintained to capture intercontinental specific CMC requirements for submissions. Take responsibility to communicate these requirements to corresponding stakeholders to maximize anticipation of needs and accelerate submissions planning.
- Take responsibility to coordinate Regulatory CMC Intelligence activities through consolidation, contribution, and coordination of comments on relevant regulations and guidelines. Ensure contributors are in place in corresponding forums to influence the regulatory CMC environment and provide feedback for Ipsen, as well as being able to anticipate on future requirements. In this context ensure working groups are set-up with corresponding stakeholders to ensure future requirements are captured in our ways of working.
- Ensure systems, tools and interfaces are in place with all associated functions/ stakeholders to allow effective and collaborative working relationships.
- Support line manager on budget/ resource planning.
- Establish and maintain training matrix for the team in line with responsibilities and activities.
- Initiate, lead, participate in and/or deliver various projects, in support of the company's objectives to improve efficiency, effectiveness, compliance and costs.
- Ensure standard content dossier section templates are created and shared with stakeholders and ensure maintenance.
- Coach and mentor team members to develop their continuous improvement skills and support them in the delivery of appropriate improvement projects.
- Promote and utilise tools and techniques to achieve continuous improvement and value creation.
- Take responsibility to extract the data and make them available for the business and digitalize the practices.
- Monitor industry trends and regulatory changes to proactively adjust processes and systems.
Knowledge, abilities & experience
Education / Certifications:
Advanced degree in Life Sciences, Information Technology, Regulatory Affairs, or related field
Experience / Abilities:
- Minimum 10 years’ experience in pharmaceutical CMC environment.
- Experience in regulatory processes, with knowledge for regulatory submissions and approvals.
- Experience in strategic planning, execution & reporting of regulatory data
- Experience in transforming organizations and way of working
- Experience in overseeing IT business system & data management
- Strong and proven business acumen
- Experience with eDMS systems for regulated environments.
- Strong ownership and cross boundary working mindset.
- A strong capability in analytical and problem solving.
- Strong ability of lobby, influence, and negotiation
- Strong ability to map and define end to end processes.
- Continuous improvement mindset
- Strong written, verbal, and interpersonal communication skills, ability to deal with people at all levels across all functions in a global environment.
- Self-motivated, curious, willing to challenge, able to support cross functional teams.
- Strong leadership and team management skills, with the ability to inspire and motivate diverse teams and to drive cultural change.
Languages:
Key Technical Competencies Required
- Strong understanding of global regulatory requirements and compliance standards
- Proficient in advanced analytics, IT business systems & data management
- Strong interest in Artificial Intelligence and new technology
- Strong automatization & digitalization technical skills
- Ability to use standard project management tools.
- Proficient in Veeva Vault RIM and other regulatory Systems
- Proficient in all native Microsoft apps (office, Teams, Sharepoint, MS project etc…), Power BI, Visio.
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include 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 perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.
