Regulatory Affairs Associate

SE Regulatory Affairs Associate

• Location: Bogotá

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Research and Development team as Regulatory Affairs Associate.

Mission statements:

• Elaboration of dossier for LCM variations (CMC, Labeling, Admin) and renewals according to local requirements (all products categories, including Biological and vaccines). Elaboration of HAQ responses according to strategies defined by CRM.
• Elaborate and follow up dispatch plan in alignment with affiliate’s priorities and established deadlines according to process type.
• Generate and propose to the regulatory affiliate regulatory submission strategies for the CMC variations received
• This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data and with ability to prioritize among workloads and multiples sources of demands.

Main responsibilities:

• Responsible for CP verification, dossier elaboration and dispatch of products from relevant BUs to the countries in charge, ensuring compliance with local regulations and accomplishing timing needs.
• Responsible for the dispatch plan of respective dossiers.
• Focal point for communication with customers / interfaces (e.g.: RSO and Global CMC, Operation, labelling, IVT etc)
• Preparation of Risk Assessments of the dossiers before dispatch, including technical viability, when applicable.
• Responsible for review of CP completeness and gathering missing documents/information from responsible teams for the completion of dossier to be dispatched, according to the legislation (i.e., CMC and Administrative docs: GMP, PoA, trademarks certificates, etc, Clinical/ non clinical, BE as needed, PV docs, local forms, Artworks, Samples).
• Translation of the dossiers when required by legislation.
• Ensure the quality of dossiers, identifying possible requirements that may be presented, in order to avoid processing times increase.
• Responsible to include in database the dossier and legal documents dispatched to the countries.
• Participation in internal meetings and external meetings for training.
• Ensure timely dispatch of dossier to the countries in charge.
• Make follow-up to RSO of manufacturing site/CMC team, IVT assuring the dispatch of necessary documents for dossier.
• Answer opportunely the deficiency letters issued by Health Authorities of the countries in charge.
• Give accurate and timely information to maintain regulatory data base updated
• Give visibility to the upper management of main challenges faced locally and provide suggestions of improvement whenever applicable

About you

• Experience: Preferably have worked in similar positions in the pharmaceutical industry with biological and vaccines.
• Soft and technical skills: Strive for results, Commitment to Customer, Cooperate Transversally.
• Demonstrated and recognized capacity to work in a matrix organization
• Strong teamwork ability: interpersonal & communication skills
• Demonstrated capacity to Act for Change
• Ability to Make Decisions
• Excellent strategic, networking and influencing skills
• Communication and influence
• Strong Knowledge of regulatory affairs
• Education: Pharmaceutical Chemical Professional
• Languages: Good level of reading, spoken and written English and Spanish

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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