Regulatory Affairs Capability Director

Responsible for the development and implementation of functional learning/training opportunities and needs, aimed to enhance the knowledge, skills and competencies necessary to drive regulatory strategy and to secure organizational readiness for systems upgrades and roll-outs. This role involves identifying and defining the required skills, analyzing current capabilities, identifying gaps, implementing training programs and relevant communication within and outside Regulatory Affairs functions.

Key responsibilities

• Develop plans to address identified functional learning opportunities/needs, necessary to enhance the team's knowledge and skills in regulatory affairs.
• Partner with Process Director, Learning Manager, System Lead and Compliance Lead as applicable to develop effective process and compliance trainings to support organizational readiness of processes and associated systems and technology.
• Collaborate with stakeholders, and subject matter experts, multi-functional teams, to define learning objectives and requirements.
• In partnership with Systems team and respective Process Director, support the E2E training preparation and roll-out for new system implementation ensuring that the Regulatory Affairs user community is prepared for the implementation and uptake of new or enhanced tools in support of their business activities.
• Develop user-friendly and impactful learning material to support select policy/RegIntel related initiatives.
• In alignment with respective RA team lead(s), and in collaboration with Global Development University/Novartis Learning Institute, develop and implement a lean learning concept with role specific, right-sized, and right-timed learning.
• Oversight on cross functional training and Knowledge Management (KM) initiatives and opportunities.
• Liaise with other groups as applicable to leverage common training approaches, tools and techniques to ensure that employees have access to the necessary resources and opportunities to enhance their skills, knowledge, and competencies.
• Ensure that training programs are fit-for-purpose and aligned with industry best practices and regulatory requirements.
• Develop and maintain RA basis “universal” on-boarding package.
• Support RA hiring managers with development of material to support target on-boarding of new joiners and post-graduate as needed.
• Ensure implementation of the right training approach(es) and just in time learning solutions to maximize learning efficiency and end-user adherence.
• Represent RA in Divisional Training Governance and Forums or equivalent.
• Establish metrics and evaluation methods to assess the effectiveness of capability enhancement initiatives.
• Regularly monitor and report on the progress and impact of training programs.

Essential Skills

• Education: Life Science Degree or other University degree with equivalent experience.
• Experience and skills: Regulatory and drug development experience.
• Strong knowledge on E2E process, supporting system, regulations and business change(s).
• Proven successful experience on the design and development of training concepts with cross-functional teams.
• Organizational awareness, including significant experience working cross-functionally.
• Proven ability to influence change and act as change advocate.
• Experience in Project management tools & systems.
• Technology-savvy – ability to leverage and use systems, technology and automation to derive impactful trainings and communications.
• Strong communication skills.
• No direct report – working with multiple stakeholders in a matrix environment.

Skills Desired

• Clinical Trials
• Cross-Functional Teams
• Drug Development
• Lifesciences
• Negotiation Skills
• People Management
• Problem Solving Skills
• Regulatory Compliance
• Risk Management
• Strategy Execution