Regulatory Affairs Associate

Regulatory Affairs Associate

• Location: Bogotá, Colombia

About the job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

TheRegulatory Affairs Associate will ensure the design and implementation of regulatory plans considering business unit priorities and global guidelines, drive by anticipation and seeking predictability in processes. Ensure the maintenance of the business unit portfolio within the regulatory framework of each country, always using regulatory best practices and optimization of resources and processes at the COPAC region level (Pharma BU).

Main responsibilities:

• Ensure dossier preparation plans are deployed and submit requests, reports or any correspondence required to regulatory agencies in accordance with the regulatory strategy of the MCO.
• To be a strategic ally of SE and GRA teams, contribute to LCM strategies.
• Develop regulatory strategies and implementation plans for the preparation and presentation of new products and lifecycle activities aligned with business priorities and global regulatory standards.
• Contribute to the development of the strategic and operational plans of the business units.
• Provide responses to regulatory agencies regarding product information.
• Management of submissions and colaborative work with external regulatory agents.
• Actively contribute to compliance with regulatory policies and procedures.
• Establish regulatory priorities and optimize budget execution.
• Provide regulatory guidance to development project departments and teams regarding product design, development, evaluation and marketing.
• Monitor trends in the regulatory environment of each of the countries in the region, in order to generate influence on them and contribute early to business strategies, including close monitoring of products that are or may be competitors of BU therapies.
• To build and maintain a close relationship with Health Authorities, attending appointments, meetings and other activities necessary to shape the regulatory framework in order to continue the business.
• Ensure accurate and timely data entry and information on all platforms/databases with regulatory actions.

About you

• Experience: +2 years of experience in the pharmaceutical sector on regulatory affairs, knowledge in biological drugs is desirable.
• Soft and technical skills: Project management and teamwork. Orientation to detail in the coordination and execution of regulatory submission plan in accordance with the requirements of each country. Assertive communication with internal and external stakeholders, verbal and written. Positive and effective influence. Understanding of strategic priorities of the area and alignment of the work plan with the objectives of the Business. Strong organizational skills and ability to prioritize workload. Strong knowledge of regulations in Colombia, experience in other LATAM countries is a plus.
• Education: Bachelor degree in pharmaceutical sciences.
• Languages: Intermediate- Advanced English level required.

Why choose us?

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• You’ll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions.
• You’ll be part of a truly diverse cross-cultural team and can have real business impact.
• Flexible working policies, including up to 50% remote work.
• Private medical care, life and health insurance, and gender-neutral paid parental leave
• Colombia is one of Sanofi’s key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation.
• Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants.

PursueProgress. 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

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