Regulatory Affairs Excellence Manager

Job description

Location: Budapest (Hungary)

Job type: Unlimited term, Full time

About the job

At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.

In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.

Our Team:

SA Quality & Excellence is a diverse and inclusive team striving to Build a culture of excellence by:

·  Driving the strategic direction for Quality and promoting the quality culture within the organization
·  Setting up the governance to ensure implementation of our standards and policies across the organization Transforming our services and processes to enable our teams to focus on value creation and developing our talent cross Science Hub
·  Making Sanofi CHC an industry leader in Scientific engagement through innovative strategies and digital

Main responsibilities:

Operational

Ensure business continuity & deliver the operations without disruption

The RA excellence manager will be responsible for designing the overall translation strategy, defining the end-to-end process, preparing the annual planning including the budget and coordinating the individual requests (e.g. Receive, analyse, prioritize requests, coordinate the delivery, ensure all relevant information is provided to the translators):

·  Design the translation strategy
·  Start building and implement process
·  Define the end-to-end translation process to fit for CHC organization
·  Coordinate the process with internal and external stakeholders
·  Ensure proper deployment of the translation machine new technology
·  Establishing deliverables, timelines, and deadlines,
·  Recruiting, contracting, and managing suppliers (translators and reviewers),
·  Ensure the vendors' oversight
·  Forecasting and follow up costs (Forecasting budgets of translation)
·  KPI development and reporting
·  Training and communication execution
·  Be the key contact in case of audits and inspections

About you

Experience:

·  General Regulatory affairs experience including but not limited to an overview in regulatory dossiers dispatch/ submissions, labelling, variation.
·  Translate the process into a LEAN manner.

Soft skills:

·  Change mindset
·  Solution orientated
·  Resilient and embrace the change
·  Able to influence stakeholders
·  Strong customer centric/stakeholder centric mindset
·  Strong communication and presentation skills
·  Ability to collaborate in a rapidly evolving environment, very comfortable with change
·  Ability to interact effectively with business stakeholders
·  Strong ability to build and maintain networks both internally and externally

Technical skills:

·  Previous experience in project management or business analysis is desirable
·  Excellent computer skills incl. MS Office

Education:

·  Bachelor’s degree in Life Sciences, Engineering or related or equivalent,
·  Professional project management qualification such as PMP® desirable

Languages:

·  Strong command of spoken and written English is mandatory

If the description fits your experience and has captured your interest, please apply so we can get in contact with you!

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.

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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Pursue Progress . Discover Extraordinary .

Visit our external career site for more opportunities and information: 

https://www.sanofi.hu/hu/karrier

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.