Regulatory Affairs Specialist
(External & unlimited contract, based in Bucharest, Sanofi office)
Regulatory Affairs Specialist (external contract, unlimited period)
About the Opportunity
Reporting directly to Regulatory Team Lead, you will play an integral role in the Sanofi Regulatory family. By developing and maintaining this diversified portfolio, you will have an impact on improving the life of many patients. As Sanofi develops, you will be well placed to continue to develop in your role.
About Sanofi Regulatory Affairs Global Function
Sanofi Regulatory Affairs Function is an agile partner of the diverse Sanofi business units and platforms working effectively as a single regulatory community. We build constructive relationships with key external stakeholders, at global and local levels. We are a creative organization, dedicated to tailor patient-centric solutions and make them available for all patients, and to harmonize best regulatory practices.
- Managing with maximum efficiency the assigned Regulatory Affairs tasks, according to the global strategy, the affiliate needs and national regulations.
- Ensuring the maintenance activities allocated, according to the company Quality Standards, SOPs and Quality Guidelines and the common regulatory KPI of the local and Global teams.
- Managing with accuracy the labelling and the specific Romanian packaging and maintaining accurate records of all regulatory procedures.
- Providing documentation and support to the other affiliate functions regarding regulatory aspects.
- Maintaining and developing optimal scientific relationships with the competent authorities.
To excel in this role you will need to have:
- Pharmaceutical or medical university studies, completed with bachelor degree.
- Minimum 1 year experience in an international pharmaceutical company, on a similar position, relevant courses of pharmaceutical legislation, regulations, pharmacology, pharmaceutical technology. Drug control experience is an advantage.
- Strong understanding and adherence to industry ethics and compliance principles
- Comprehensive scientific understanding.
- Thoroughness, accuracy, precision, diplomacy, intuition.
- Integrity, tenacity, resistance and adaptability to complex situations and to a rapidly changing environment.
- High level of self-motivation and sense of individual responsibility.
- Foreign languages: excellent English language skills, good knowledge of French language.
It would be advantageous to have:
- Deep knowledge on current regulations and practices, related to the laws and regulations from Romania and the EU
- Ability to prioritize and successfully execute multiple tasks simultaneously
- Ability to work in a team, respecting the needs of those involved
- Ability to build relationships across departments and functions and to support a collaborative working environment
- Ability to manage stress and work under pressure, to commit and respect the individual and team deadlines
- Sense of urgency, punctuality, availability to work extra-hours
- Intercultural adaptability and sensitivity
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.
- You will be based in our Green Court centre, close to metro station, taking approximately 10 minutes’ walk to the office.
- We have a cafeteria in the office space, and immediate access to a restaurant with healthy food, in the building.
- This is a full time role and we support flexible working.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and 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 employees, patients and customers.
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, 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