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Global Regulatory Affairs Business Process Specialist (GRA BPS)

AT Sanofi U.S.
Sanofi U.S.

Global Regulatory Affairs Business Process Specialist (GRA BPS)

Dabas, Hungary
  • Location: Budapest
  • Flexible working: 60% home, 40% office
  • Job type: Permanent, Full-time


About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join us as Global Regulatory Affairs Business Process Specialist (GRA BPS) and you will play a critical role in supporting the Global Regulatory Affairs Business Process Owner (GRA BPO) by driving the development, implementation, and continuous improvement of assigned business processes, to accelerate the implementation of the BPO roadmap.

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As the BPO's primary resource you will be responsible for managing processes end-to-end, from initial development through integration into Signavio. This role includes monitoring performance, coordinating governance, and fostering collaboration across various stakeholders to ensure process effectiveness, compliance, and alignment with strategic goals.

Main Responsibilities:
  • Work with the BPO and SMEs to define, streamline and standardize processes, ensuring they comply with regulatory requirements and organizational standards
  • Design process flows and ensure clear roles and responsibilities through a detailed RACI (Responsible, Accountable, Consulted, Informed) matrix for each process, ensuring accountability and reducing ambiguity
  • Ensure that all processes are effectively integrated into the Signavio platform for centralized process management, transparency, and alignment
  • Design standardized workflows that incorporate both human and AI elements, as an essential element for creating efficient, adaptable processes
  • Enable and collaborate with BPOs and SMEs to identify and implement improvements in processes, focusing on efficiency, quality, and effectiveness
  • Maintain up-to-date process documentation, aligning with regulatory and quality standards as required
  • Collect and analyse performance metrics on processes to evaluate effectiveness, support continuous improvement, and report insights to the BPO
  • Work closely with Regulatory Compliance and Performance Office (CoPO), Business Analytics, and Capability Leads, among others, to ensure seamless process execution and alignment
  • Act as the liaison between various departments/SMEs, facilitating cooperation and knowledge-sharing across the business process network
  • Act as a point of contact for process-related questions and issues, working with relevant teams to resolve challenges promptly and minimize operational disruptions

About you

Education:
  • Bachelor's degree in business administration, Process Management, or related field (master's preferred)
  • Formal certification on Lean Six Sigma, Certified Business Process Professional (CBPP) and/or AI in Business Process Management is a plus

Experience:
  • Experience in regulatory affairs or a solid understanding of GxP (Good Practice) and regulatory standards applicable to the pharmaceutical industry, with demonstrated experience in process improvement and project management
  • Strong understanding of processes and requirements within the pharmaceutical industry (knowledge about regulatory environment could be an advantage)
  • Deep knowledge of process mapping and design techniques, especially in tools like Signavio or similar BPM (Business Process Management) tools
  • Experience in leading training initiatives and providing support to teams during process transitions

Skills:
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
  • Proven ability to think strategically and translate strategic objectives into actionable plans
  • Results-oriented mindset with a focus on driving continuous improvement and achieving measurable results
  • Ability to work independently and manage multiple priorities in a fast-paced environment
  • Digital driven appetite and mindset are a must

Language:
  • Very good oral and written communication skills in English.

Why choose us?
  • Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
  • Work from an "Office of the Year 2023" award winner with flexible home office policy
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave
  • An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
  • Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue progress, discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people's lives. Please ensure to have read this document before applying.

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Client-provided location(s): Hungary
Job ID: Sanofi-https://jobs.sanofi.com/en/job/budapest/global-regulatory-affairs-business-process-specialist-gra-bps/2649/19279059968
Employment Type: Other