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- Tasks: Lead regulatory quality processes and ensure compliance across global functions.
- Company: Join Novartis, a leader in reimagining medicine for better patient outcomes.
- Benefits: Enjoy hybrid work options and a supportive, inclusive culture.
- Why this job: Make a real impact on patients' lives while collaborating with passionate teams.
- Qualifications: Experience in Regulatory Affairs within the pharmaceutical industry is essential.
- Other info: Opportunity to participate in cross-functional projects and internal audits.
The predicted salary is between 48000 - 72000 £ per year.
Manager Regulatory Affairs Process Excellence
Job ID REQ-
United Kingdom
Summary
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
This role offers hybrid working, requiring 3 days per week in our Whitecity, London office.
In this role you will be responsible for the development and implementation of regulatory quality processes and procedures, aligning with global RA and other functions. You will also support the implementation of initiatives within RA to support a quality system. This involves establishing and maintaining a comprehensive set of clear, consistent RA policies and procedures that align with global functions, both within and external to RA, and across Novartis Business Units.
About the Role
Key Accountabilities:
- You will oversee and manage business processes and their links to systems, and own certain business processes within the assigned business process area.
- Drive and coordinate with business process owners, the end-to-end process strategy within respective area to ensure alignment within and outside RA.
- Drive and implement continuous process improvement strategies or closure of process gaps across process area. Point of contact for other functions outside RA for process alignment and new process implementation within respective area.
- Support quality and consistency of RA regulatory compliance activities in assigned region through implementation of new processes, policies, metrics and appropriate training, and ensuring data compliance in the global RIM system.
- Partner with Region Head, Sub-region Heads, and Subject Matter Experts from assigned region to implement and track training for policies, processes and procedures.
- Participate in cross-functional process improvement projects to represent the function; help to identifying resources from the function to support cross-functional projects.
- Support the preparation of the RA organization for internal global audits including CAPA management, collaborating with QA to prepare RA/ Country Organisations for external inspections at HQ including CAPA management.
- Work with Director RA Process Excellence to address potential quality issues and emerging compliance concerns and recommend solutions, providing backup support, as needed.
Your experience:
- Pharmaceutical industry experience, in Regulatory Affairs.
- Demonstrable experience in working knowledge of SOPs and compliance.
- Good interpersonal, negotiation and communication skills.
- Experience working in complex global environments and cross-functional teams.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Manager Regulatory Affairs Process Excellence employer: Novartis Farmacéutica
Contact Detail:
Novartis Farmacéutica Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager Regulatory Affairs Process Excellence
✨Tip Number 1
Familiarize yourself with the latest regulatory guidelines and compliance standards in the pharmaceutical industry. This knowledge will not only help you understand the role better but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in Regulatory Affairs, especially those who have experience in process excellence. Engaging with industry peers can provide valuable insights and potentially lead to referrals or recommendations for the position.
✨Tip Number 3
Highlight any experience you have with cross-functional teams and process improvement initiatives. Be prepared to discuss specific examples of how you've successfully implemented changes or improvements in past roles.
✨Tip Number 4
Research Novartis' current projects and initiatives in Regulatory Affairs. Understanding their strategic goals will allow you to tailor your discussions during interviews and show how your skills align with their objectives.
We think you need these skills to ace Manager Regulatory Affairs Process Excellence
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Manager Regulatory Affairs Process Excellence position. Highlight key responsibilities and required skills that resonate with your experience.
Tailor Your CV: Customize your CV to reflect relevant experience in regulatory affairs, process improvement, and compliance. Use specific examples that demonstrate your ability to manage business processes and implement quality systems.
Craft a Compelling Cover Letter: Write a cover letter that connects your background in the pharmaceutical industry with the role's requirements. Emphasize your interpersonal skills and experience in cross-functional teams, showcasing how you can contribute to Novartis' mission.
Highlight Continuous Improvement Experience: In your application, be sure to mention any previous roles where you successfully drove process improvements or managed compliance initiatives. This will align well with the expectations of the position.
How to prepare for a job interview at Novartis Farmacéutica
✨Understand Regulatory Affairs
Make sure you have a solid understanding of regulatory affairs processes and compliance in the pharmaceutical industry. Be prepared to discuss your experience with SOPs and how you've navigated complex regulatory environments.
✨Showcase Process Improvement Experience
Highlight any past experiences where you've successfully implemented process improvements. Be ready to provide specific examples of how you identified gaps and drove changes that enhanced efficiency or compliance.
✨Demonstrate Interpersonal Skills
Since this role requires collaboration with various stakeholders, emphasize your interpersonal and communication skills. Prepare to discuss how you've effectively worked within cross-functional teams and managed relationships with different departments.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities in real-world situations. Think about challenges you've faced in regulatory affairs and how you approached them, particularly in relation to audits and compliance.
