Regulatory Affairs Associate

About The Job

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main Responsibilities

• Ensure to file new product registration and update the current registration file in timely manner
• Renew and revise the existing product license to ensure all are valid and compliance with regulation
• Maintain currency of labeling, pack leaflets in accordance with local regulations and corporate data sheet
• Ensure accurate translations of relevant documents
• Establish good relationship with Health Authority officers
• Establish good relationship with GRA regional/global regulatory staff for regular contact
• Provide cross-functional support needs in the organization
• Participate in workshop, symposium related to regulatory affairs changes at a country level; share with other team members the latest information related to his/her works
• Being able to propose solution to different problem and discuss with his/her direct report
• Perform other duties as assigned by management.
• Sanofi employee must understand of own roles and responsibilities in avoiding health risk (Health), preventing accidents (Safety) and environment protection (Environment). Involved in any such activities must comply with HSE policy.
  
  

Education

About You

• Scientific background (Pharmacy or related field) essential
  
  

Experience & Knowledge

• At least 2 years experience in regulatory affairs field
  
  

Core Competencies / Skills

• Demonstrates knowledge and practice in the regulatory field
• Demonstrates capacity to learn and understand business, legal, financial and human resource
  
  

issues and their impact on the regulatory function

• Highly focused and drives to set for him/herself ambitious objectives
• Quick to analyze and take action without compromising quality; utilizes effective negotiation skills
• Shows integrity, tenacity, resilience and adaptability in complex situations; able to handle pressure and commit to and respect deadlines
• Demonstrates cooperative attitude both among team members and with other colleagues in the company
• Demonstrates good English language skills
  
  

Why choose us

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
  
  

nullPursueProgress. DiscoverExtraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives Let's Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.