The Global Regulatory Affairs (GRA) team plays a critical role in regulatory strategy, guiding product development, and ensuring successful global submissions and approvals.
Key Responsibilities:
- Develop and implement regulatory strategies for global biosimilar product registrations.
- Coordinate cross-functional teams to support product development, approval, and long-term planning.
- Prepare and maintain high-quality regulatory documents (e.g., CTAs, IND/IMPD, MAA/BLA).
- Provide regulatory guidance on global requirements to support product development.
- Lead regulatory compliance efforts and participate in meetings with health authorities.
- Monitor global regulatory requirements, assess impacts, and generate biosimilar intelligence.
- Collaborate with internal and external partners to execute approved regulatory strategies.
Required Skills:
- Comprehensive understanding of regulatory activities.
- Experience with regulatory filings and product registrations.
- Strong teamwork skills, especially in working with partners.
- Familiarity with project management.
- Ability to understand and communicate scientific CMC information.
- Anticipate and prevent potential regulatory issues.
Qualifications:
- Relevant experience in Global Regulatory Affairs, particularly in biosimilars or biologics.
- Strong knowledge of global regulatory requirements and guidelines.
- Excellent communication skills and ability to work collaboratively.
