Offer summary

Qualifications:

Life Science Degree or equivalent experience in regulatory affairs., Strong knowledge of end-to-end processes and regulatory requirements., Proven experience in designing and developing training concepts with cross-functional teams., Excellent communication skills and ability to influence change..

Key responsibilities:

Develop and implement training programs to enhance regulatory affairs knowledge and skills.

Collaborate with stakeholders to define learning objectives and support system implementations.

Create impactful learning materials and ensure training programs align with industry best practices.

Establish metrics to assess the effectiveness of training initiatives and report on their progress.

Job description

Job Description Summary

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

Job Description

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 - within the concept of Learning in the Flow of Life (knowledge management enabled, role specific, just in time learning).

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 (eg concept, strategy, design, tools) and roll-out (eg communication, reflect in relevant training systems) for new system implementation (eg FreeWay) 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) (eg instructor-led, web-based, virtual training, micro-learning, innovative learning approaches and technology) 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 (including digital assistants and AI tools) 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

Required profile