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- Tasks: Lead the development of training programs to enhance regulatory affairs skills and knowledge.
- Company: Join a leading organisation focused on innovative drug development and regulatory excellence.
- Benefits: Enjoy flexible work options, professional growth opportunities, and a collaborative culture.
- Why this job: Make a real impact by shaping training strategies that drive regulatory success and organisational readiness.
- Qualifications: Life Science degree with regulatory experience; strong project management and communication skills required.
- Other info: Work in a dynamic, cross-functional environment with no direct reports, fostering teamwork and collaboration.
The predicted salary is between 54000 - 84000 £ per year.
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 (e.g. concept, strategy, design, tools) and roll-out (e.g. communication, reflect in relevant training systems) 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) (e.g. 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 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
Regulatory Affairs Capability Director employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Capability Director
✨Tip Number 1
Familiarise yourself with the latest trends and regulations in regulatory affairs. This will not only help you understand the role better but also allow you to engage in meaningful conversations with stakeholders during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry conferences or webinars, and connect with people on platforms like LinkedIn. This can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with training development and implementation. Be ready to share specific examples of how you've successfully enhanced team capabilities in previous roles, as this is a key aspect of the job.
✨Tip Number 4
Showcase your project management skills by discussing any relevant tools or methodologies you've used. Highlighting your ability to manage cross-functional teams and projects will demonstrate your fit for this role.
We think you need these skills to ace Regulatory Affairs Capability Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, training development, and cross-functional collaboration. Use specific examples that demonstrate your ability to enhance team knowledge and skills.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and your understanding of the role's requirements. Mention how your background aligns with the company's goals and how you can contribute to their training initiatives.
Showcase Relevant Skills: Emphasise your project management experience, technology proficiency, and communication skills. Provide examples of how you've successfully implemented training programs or influenced change within an organisation.
Highlight Collaborative Experience: Since the role involves working with multiple stakeholders, include instances where you've collaborated with cross-functional teams. This will demonstrate your ability to work effectively in a matrix environment.
How to prepare for a job interview at Novartis
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of current regulations and compliance standards in the pharmaceutical industry. Familiarise yourself with recent changes and how they impact regulatory affairs, as this will demonstrate your expertise and readiness for the role.
✨Showcase Your Training Development Experience
Prepare to discuss specific examples of training programmes you've developed or implemented in the past. Highlight your ability to identify learning needs and create effective training materials that enhance team capabilities in regulatory affairs.
✨Emphasise Cross-Functional Collaboration
Be ready to talk about your experience working with diverse teams and stakeholders. Illustrate how you've successfully partnered with others to achieve common goals, especially in developing training strategies or implementing new systems.
✨Demonstrate Change Management Skills
Since the role involves influencing change, prepare to share instances where you've acted as a change advocate. Discuss how you managed resistance and ensured smooth transitions during process upgrades or training roll-outs.
