Regulatory - Talent Pipeline
Istanbul, TURKEY Personal services
Job description
Ready to learn more about us?
We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.
Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to make the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our commitments.
We are one of the largest pharmaceutical companies in Turkiye, serving public health for with more than 1,600 employees. Adding value to local economy and development in Turkiye, we offer a broad range of products including innovative therapeutic solutions, biotechnological pharmaceuticals, vaccines, and consumer healthcare products.
Our factory in Luleburgaz is one of the leading pharmaceutical manufacturing plants in Turkiye. It is also among the top three Sanofi production sites worldwide in terms of its manufacturing capacity. Our manufacturing site produces high-quality pharmaceuticals in many different forms in accordance with global health standards and develops generic medicine at its on-site R&D Center.
Job Overview
The position will be part of the Turkiye Regulatory Unit .
General Key Responsibilities
· Propose and implement a regulatory strategy / approach (when and how) for new submissions.
· Responsible to know, to adhere to and to advise others on Regulatory Authority regulations and guidance.
· Participate in other projects and activities, such as leading implementation of changes to processes.
· Ensure submissions of new chemical entity / new generic product / line extensions / new indication according to planned submission dates.
· Ensure new product packaging and associated information are updated, timely implemented, and maintained in accordance with the current product licenses.
· Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national and local regulations.
· Act as the primary interface between the company and local regulatory authorities
Requirements & Qualifications
· Minimum bachelor’s degree in medicine, pharmacy, chemistry sciences or other relevant life sciences
· Fluent in English both written and spoken.
· Knowledge of Turkish is must
· Preferably experience in a pharmaceutical company
· Excellent understanding of the pharmaceutical industry, drug development environment, and company processes and objectives
· Strong interpersonal skills to motivate his/her team and liaise effectively with internal and external contacts.
· Ability to work with multifunctional and multicultural teams.
· Desirable to have solid interpersonal skills and be adaptable to challenges.
· Demonstrate strong analytical & organizational skills with the ability to handle multiple tasks and prioritize.
· Ability to develop important relationships with key stakeholders.
· Able to operate in a cross-cultural and complex matrix environment.
· Outstanding process and project management skills.
Joining a Talent Pipeline in Sanofi
By applying to our Talent pipeline, you will get the opportunity to be considered for the potential Regulatory positions that will open in the future.
You will only be contacted if we find a relevant position that matches your profile, but you will remain part of the Pipeline unless you inform us that you wish to withdraw.
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.