**_Regulatory Affairs Associate_** + _Location: Bogotá, Colombia_ + _Type of role: Permanent, Full time_ **_About the job_** Ensure the design and implementation of regulatory plans considering business unit priorities and global guidelines, always relying on factors such as anticipation and seeking predictability in processes. Ensure the maintenance of the business unit’s portfolio within the regulatory framework of each country, always using the best regulatory practices and optimization of resources and processes at the COPAC region level. **Main responsibilities:** + Prepare and submit applications, reports or correspondence from regulatory agencies in accordance with the MCO’s regulatory strategy. + Be a strategic partner of the SE and contribute to LCM strategies. + Develop regulatory strategies and implementation plans for the preparation and presentation of new products aligned with business priorities and global regulatory standards. + Contribute to the development of strategic and operational plans for business units. + Provide answers to regulatory agencies regarding product information. + Actively contribute to compliance with regulatory policies and procedures. + Establish regulatory priorities and optimize budget execution. + Provide policy guidance to development project departments and teams on product design, development, evaluation and marketing. + Monitor the trends of the regulatory environment in each of the countries of the region, in order to generate influence on them and contribute in advance to business strategies, including close tracking of products that are or may be competitors to BU therapies. + Build and maintain a close relationship with the Health Authorities, attending appointments, meetings and other activities necessary to shape the regulatory framework for business continuity. + Ensure accurate and timely data entry on all platforms with regulatory action. **_About you_** + **Education:** Qualified Professional Pharmacist (registered in the relevant countries) + **Experience:** 5 years of regulatory experience. Extensive knowledge of pharmaceutical regulations for countries in the region. + **Skills:** Project management and teamwork. + Detailed guidance in the preparation and execution of the regulatory submission plan according to c/country requirements. + Assertive communication with internal and external stakeholders, verbal and written. + Positive and effective influence. + Understanding strategic priorities of the area and alignment of the work plan with business objectives. + **Language** : Intermediate-advanced English level mandatory. **Pursue** _Progress_ . **Discover** _Extraordinary_ . 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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together. 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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! \#LI-LAT \#LI-HYBRID **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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)