Fresenius Medical Care is hiring a Regional Associate, Quality and Regulatory Affairs – Asia Pacific in Gurugram, Haryana. The full-time, onsite position focuses on regulatory affairs activities for pharmaceutical products and medical devices across Asia Pacific markets.
The role involves regulatory lifecycle management, CMC variations, labeling, safety updates, annual reports, regulatory submissions, post-market requirements, artwork management and regulatory strategy across multiple APAC countries.
The Regional Associate will work with Country Local Regulatory Affairs (LRA) teams, Cluster Hubs, Global CDRA and labeling teams to support regional regulatory projects and implementation.
Job Responsibilities
The selected candidate will be responsible for:
- Managing the regulatory lifecycle of pharmaceutical products and medical devices across Asia Pacific markets.
- Supporting administrative and CMC variations, labeling activities, safety updates and annual reports.
- Working with Country LRA, Cluster Hub, Global CDRA and labeling teams on regulatory strategies.
- Preparing and reviewing regulatory strategies for projects across APAC countries.
- Reviewing and maintaining product labels and ensuring the correctness of label content.
- Managing regulatory projects across Asia Pacific markets.
- Acting as a subject matter expert for regulatory teams.
- Providing solutions and troubleshooting support for regulatory project-related issues.
- Maintaining regulatory records and updated product registration information.
- Coordinating post-market approval requirements with APAC countries.
- Supporting activities involving PSURs, health-authority notifications and quarterly reports.
- Supporting reporting activities related to adverse drug and medical-device incidents.
- Monitoring applicable national and regional regulatory requirements.
- Communicating regulatory requirements to relevant internal stakeholders.
- Supporting implementation of new regulatory requirements.
- Updating regulatory databases according to departmental requirements.
- Handling registration, regulatory submissions and artwork management systems.
- Reviewing national and hub regulatory topics against business requirements and regional RA strategies.
- Developing and implementing SOPs related to regulatory affairs processes.
Key Skills for Regional Regulatory Affairs
This position particularly involves experience or knowledge in areas such as:
Regulatory Lifecycle Management
Managing regulatory activities throughout the product lifecycle across APAC markets.
CMC & Regulatory Submissions
Supporting variations, registrations, submissions and associated regulatory documentation.
Labeling & Artwork Management
Reviewing label content and managing regulatory artwork requirements.
Post-Market Regulatory Affairs
Coordinating PSURs, health-authority notifications, safety reporting and other post-approval requirements.
APAC Regulatory Strategy
Supporting regulatory strategies and requirements across multiple Asia Pacific markets.
Qualifications
degree in Pharmacy, Life Sciences or related field
Benefits and Work Environment
The employer-provided information confirms that this is a:
- Full-time position
- Onsite role
- Gurugram, Haryana locationGurugram, Haryana
- Regional Asia Pacific regulatory affairs position
How to Apply
