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.
About You
Education:
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.
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!