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Global Regulatory Strategic Platform Analyst

Synthorx

Synthorx

IT, Legal
Bogotá, Bogota, Colombia
Posted on Saturday, May 4, 2024

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

We are seeking a dedicated and detailed-oriented Regulatory Affairs Analyst to join our team. In this role, you will play a pivotal role ensuring compliance with local regulations and project requirements for medicines, cosmetics, medical devices, food and/or food supplements.

Key responsibilities and duties:

Preparation and Delivery: Take charge of preparing and delivering dossiers for Registration, Renewal and Post-approval variation, including labeling, of various products, ensuring strict compliance with local regulations and project specifications.

Technical Analysis: Conduct thorough technical analysis of all documents, focusing on regulatory classification. Complete dossiers for dispatch in accordance with the legislation of the respective country.

Risk Assessment: Prepare comprehensive risk assessments for dossiers before submission, evaluating technical feasibility and ensuring all necessary requirements are met.

Deficiency Letters: Address deficiency letters issued by Health Authorities promptly and effectively, ensuring all necessary corrections and additional documentation are submitted as required.

Safety and Effectiveness: Update harmonized package insert documents with the latest safety and effectiveness information, ensuring all labeling updates comply with country-specific requirements.

Communication and Coordination: Act as the focal point for communication with stakeholders, including RSO, Global CMC and Global labeling. Maintain effective communication channels to ensure smooth workflow.

Database Management: Provide accurate and adequate information to keep the database and regulatory systems up-to-date, ensuring data accuracy and integrity.

Problem Resolution: Provide senior management with visibility of key challenges faced locally, offering valuable insights and suggestions for improvement where applicable.

Effective Communication: Maintain open communication with LRA to assess the need and applicability of labeling updates. Evaluate the impact of updates generated globally or regionally, ensuring harmonization and promptly communicate any deharmonization to key stakeholders.

Submission Strategy: Coordinate the submission strategy for labeling updates, ensuring harmonization while minimizing regulatory, commercial, and industrial impacts. Track regional activities in regulatory databases/systems, manage deviations in harmonized labeling documents, and support maintenance activities and Deficiency Letters through effective communication with CMC and administrative variations teams.

Artwork Evaluation: Evaluate the impact of safety and/or efficacy updates on harmonized artworks. Ensure timely updates of artwork text for submissions affected by safety and/or efficacy labeling changes. Collaborate with relevant areas to provide updated artworks for labeling and CMC variations, maintaining harmonization and participating in proofreading activities.

Regulatory Compliance: Stay updated with regulations impacting labeling documents for all countries under your responsibility. Propose innovative approaches to enhance labeling processes, fostering continuous improvement.

Efficient Management: Maintain good communication with LRA and/or other regional areas to identify opportunities for an efficient management of labeling variations.

Knowledge, Skills & Competencies / Language

  • Strong knowledge of regulatory and labelling changes in countries under his/her responsibility.

  • Demonstrated and recognized capacity to teamwork.

  • Strong interpersonal/communication skills.

  • Business and customer orientation.

  • Demonstrated competencies: Act for Change; Cooperate Transversally; Strive for Results; Commitment to Customer; Think Strategically and Make Decisions.

  • Knowledge in management of data in databases and working in workspace such as Document Management Systems (e.g. VAULT RIM or related) and Vistalink.

  • Proficient in the use of MS WORD, PowerPoint, Excel, Adobe Acrobat and the use of collaborative work environment tools (e.g. SharePoint, TEAMS).

  • Experience working within an international company with a complex organizational environment.

  • Spanish - Native or bilingual proficiency.

  • English - Professional working proficiency.

Education and experience:

  • Bachelor’s degree, or equivalent, in life sciences, regulatory affairs or equivalent, or related areas of study.

  • 1-2 years of relevant experience in similar position.

  • This role demands a strong background in regulatory affairs, excellent analytical skills, and the ability to work collaboratively in a dynamic environment. If you are passionate about regulatory compliance and ensuring product quality and safety, we invite you to apply and become a player in our team.

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