Offers “Sanofi”

Expires soon Sanofi

Regulatory Affairs

  • Barcelona, SPAIN
  • Legal

Job description



Regulatory Affairs

About the Opportunity

·  Participate in the local CHC regulatory strategy, guidance and leadership to the local CHC team;
·  Ensure timely submission of applications, notifications and regulatory compliance of the GBU's portfolio, with regards to the different regulatory requirements of different CHC product categories;
·  Provide excellent knowledge and expertise of the CHC regulatory environment. Participate in relevant local self-care trade associations committees. Develop and maintain excellent professional contact with Health Authorities and other Regulatory Bodies;
·  Be a partner for local CHC business to support the delivery of business objectives within the regulatory framework.

About Sanofi Business Unit

·  In this area you will find an international working environment in which you can unfold your talents and realize ideas and innovations together in a competent team;
·  An individual and structured training in your new tasks;
·  You can design your personal career path at Sanofi and we support and accompany your professional and personal development purposefully;
·  As a globally successful, growing healthcare company, Sanofi offers diverse and global career paths.

Key responsibilities

Regulatory activities:

·  Ensure timely submission and successful registration of regulatory documentation in line with local requirements, aligned with local registration strategy within Global Department GRA;
·  Ensure timely notification of foods/ food supplements, cosmetics and medical devices:
·  Maintenance of existing national Marketing Authorisations and notifications in line with local requirements and global standards.

Regulatory Intelligence:

·  To know regulatory legislation for the different products under her/his responsibility;
·  Responsible to keep RA Head, informed of new regulations and its impact as soon as informed;
·  Performs regulatory impact assessment;
·  Ensures that updates or new regulatory requirements are reflected in the internal Databases so that these are addressed.

Compliance:

·  Ensure regulatory compliance and quality;
·  Support local inspection readiness;
·  Contribute to CAPA process as appropriate;
·  Adherence to Learn timelines.

About You

·  University scientific degree;
·  Knowledge of local and international regulatory affairs regulation;
·  Knowledge of CHC regulatory affairs;
·  Relevant experience in pharmaceutical industry of at least 2 or 3 years;
·  Excellent command of English language;
·  Strong organisational and communication skills;
·  Proactive and assertive attitude;
·  Team- and networker.

What Sanofi can offer you

·  A role where you are instrumental to creating best practice and as the organisation grows, you can too;
·  We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us;
·  This is a full time role and we support flexible working.

About Sanofi

Empower Life Everyday

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we're not there to try to solve everybody's problems. We want to focus on those areas where we know we are making a difference.

The values we are live by are teamwork, courage, respect and integrity.

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.

Make every future a success.
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