(Senior) Regulatory Affairs Manager

About the job

• Prepare local documents, submit and follow up registration applications, under supervision of the Head of Affiliate Regulatory Affairs, to ensure that marketing authorizations are obtained or maintained in line with the business plan.

• Lead and be responsible for driving regulatory affairs activities for Taiwan Rare Disease portfolio.

Key Accountabilities

• 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.

• To understand local regulatory trend and seek the most benefit for company.

• Set up the local registration strategy / plan for responsible products.

• Other assigned RA projects.

• 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 in Pharmacy is preferred.

Experience & Knowledge

• At least 5-8 years experience in regulatory affairs field with good knowledge and practices in the regulatory regulation.

• With experience of completing NDA and plant registration projects.

• Experience of completing ODD and ODA is desirable.

• Work experience in TFDA and/or CDE is desirable.

Core Competencies/Skills

• Demonstrates knowledge and practice in the regulatory field

• Demonstrate high team spirit with integrity, tenacity, resilience and adaptability in complex situations

• Be able to handle pressure and commit to and respect deadlines.

• Demonstrates capacity to learn and understand medical, regulatory, especially marketing issues and their impact on the market research 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

• Demonstrates cooperative attitude both among team members and with other colleagues in the company

• Proficiency in written and spoken Chinese and English is essential.

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.

Our Values

• Aim Higher: Focus on what matters, set high standards and move with urgency to deliver at speed. Learn from setbacks to achieve tomorrow’s breakthroughs.

• Act for Patients: Improving patients’ lives drives everything we do, every day. We aim for simplicity and partner with others to go faster and further for patients. We eliminate barriers to access.

• Be Bold: Take thoughtful risks, seize opportunities and think beyond what’s possible to accelerate our science and drive compelling growth.

• Lead Together: Build trust and collaborate openly on our shared goals, celebrate collective wins and foster a sense of belonging.