Director CMC Regulatory Processes and Systems

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:

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