Job Title: Director CMC regulatory Processes and systems
Division / Function: Global Regulatory Affairs GRA
Manager (Name, Job Title): Head CMC regulatory strategy
Location: Boulogne/ Balard or Paddington
Summary / Purpose Of The Position
Provide strategic and technical CMC regulatory input to improve processes and facilitate interfaces with stakeholders for the purpose of maximizing CMC regulatory business from early development to life cycle management, facilitating submissions, approvals from CMC perspective of new assets and variations in a timely and high-quality manner.
Main Responsibilities / Job Expectations
- Responsible for mapping CMC regulatory activities at the different locations, define end to end robust simplified processes in collaboration with all stakeholders to reduce barriers to execution, define clear role and responsibility. Ensure this is documented through either standards or procedures.
- 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 CMC regulatory
- 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 system that enables CMC regulatory 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 process to initiate, plan, execute, monitor, and report on the overall CMC regulatory Portfolio activities for clinical trials applications, marketing applications and post approval activities.
- Initiate and maintain the CMC regulatory 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 CMC regulatory portfolio.
- Ensure a CMC regulatory platform is built and maintained to identify intercontinental specific 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 CMC Regulatory Intelligence activities through consolidation, contribution, and coordination of comments on regulations and guidelines relevant to CMC-Regulatory topics. Ensure CMC regulatory contributors are in place in corresponding forums to influence the CMC regulatory environment and provide feedbacks 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 effective and collaborative working relationships within the Global CMC-Reg teams and all other associated functions/ stakeholders are in place.
- Support line manager on budget/ resource planning and monitoring for CMC projects.
- Establish training matrix for the CMC regulatory 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.
- Create standard content dossier section templates to be shared with stakeholders and ensure maintenance.
- Coach and mentor CMC regulatory personnel 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.
EHS Responsibilities
- Respect and enforce applicable EHS regulations and procedures.
- Promote EHS dynamics within teams for the proper functioning of the EHS management system
- Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees
- Ensure the completion of mandatory EHS training by his collaborator
Knowledge, Abilities & Experience
Education / Certifications:
- Advanced degree in scientific discipline, major in pharmaceutical/Biological/Chemical Science or relevant scientific discipline
Experience
- Minimum 10 years’ experience in CMC regulatory affairs field in a management role
- Ideal: Significant depth of change management experience
- Proven ability to communicate (written/oral) with various functions.
- Fluency in English Ability of cross functional co-operation.
- Strong ownership and cross boundary working mindset.
- A strong capability in problem solving.
- Strong ability of lobby, influence, and negotiation
- Strong ability to map and define end to end processes.
- Continuous improvement mindset
- Ability to coordinate, influence and lead people or a virtual team.
Languages
Key Technical Competencies Required
- Proven experience in CMC regulatory on R&D portfolio and Life cycle management
- Proven advanced technical and regulatory writing experience.
- Excellent communication skills required to communicate with all levels and across all functions in a global environment.
- Proven understanding of CMC regulatory processes and requirement in US, EU, JP, China and other IC territories
- Excellent written, verbal, and interpersonal communication skills, highly organized, target orientated, clear communicator, ability to deal with people at all levels, good negotiator, ability to prioritise, ability to balance objectives.
- Strong analytical and problem-solving skills
- Self-motivated, curious, willing to challenge, able to support cross functional teams.
- Experience in transforming organisations and ways of working.
- Able to work effectively as a part of a cross-functional team and quickly develop good relationships with internal and external stakeholders.
- Ability to use standard project management tools.
