Job Title : Global Regulatory Lead, Oncology
Location : Remote or On-site (depending on client requirements)
Job Type : Contract
Overview :
We are seeking a highly experienced and skilled Global Regulatory Lead to spearhead the future of oncology products. You will drive the development of brand-new oncology products through the entire lifecycle. This is your chance to be at the forefront of oncology innovation.
This role requires expertise in both domestic and international markets. So you will be driving the product at a global scale. This will offer you the chance to increase you visibility in global oncology regulatory sphere. Not only building your career but also making you stand out as a key leader within the industry.
Key Responsibilities
- Develop global/US regulatory strategies for Oncology products.
- Lead interactions with FDA and global authorities.
- Oversee regulatory submissions (IND, BLA, NDA) for compliance.
- Write and review key regulatory documents.
- Guide US labeling strategy.
- Monitor regulatory trends to inform development.
- Build relationships with FDA and key stakeholders.
- Foster a collaborative team environment.
Experience :
- 7+ years in Reg Affairs
- Significant experience with oncology strategy
- In-depth knowledge of FDA and Global regulations
For more information apply or reach out via email address