Regulatory Affairs Strategy Expert
Fresenius Medical Care is seeking a Regulatory Affairs Strategy Expert to lead global regulatory strategy and submissions. The role involves planning and executing eCTD submissions across multiple regions including the U.S., EU, and APAC. You will represent regulatory affairs on cross-functional teams and ensure compliance with global authority requirements. The position requires strong expertise in regulatory information systems and ICH guidelines.
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Experience
8-10 years
Function
Research
Work mode
Hybrid, India
Company
Tier 2
What you will work on
Fresenius Medical Care is seeking a Regulatory Affairs Strategy Expert to lead global regulatory strategy and submissions. The role involves planning and executing eCTD submissions across multiple regions including the U.S., EU, and APAC. You will represent regulatory affairs on cross-functional teams and ensure compliance with global authority requirements. The position requires strong expertise in regulatory information systems and ICH guidelines.
TAL's take
Strong, well-defined role in a global healthcare leader with clear requirements and expectations.
Very clear scope, specific systems, and defined responsibilities within a global regulatory framework.
Must haves
- 8-10 years of global regulatory affairs experience
- Hands-on experience with global eCTD submissions
- Experience with IND, NDA, ANDA, MAA submissions
- Interaction experience with FDA, EMA, Health Canada, ANVISA
- Deep knowledge of ICH guidelines
- Proficiency with Veeva Vault RIM and RIMSmart
Tools and skills
Nice to have: rac certification.
About the company
Established global healthcare organization, though not a top-tier tech-focused unicorn.