What are the responsibilities and job description for the Regulatory Affairs Manager position at Jobleads-US?
**Company Overview:**
Iambic Therapeutics is a rapidly growing biotech company pioneering the use of AI-driven drug-discovery platforms to develop innovative therapeutics. Our team is passionate about creating life-changing treatments for patients with unmet medical needs. We are committed to building an inclusive environment where diverse perspectives and ideas thrive.
Key Responsibilities:
- Develop and implement regulatory strategies for drug development that align with business objectives and timelines
- Oversee the preparation and submission of regulatory documents to the FDA and other regulatory authorities
- Serve as primary point of contact for regulatory agencies and facilitate communication between the company and regulatory bodies
- Provide expert regulatory guidance to cross-functional teams
Benefits:
- Competitive salary
- Comprehensive benefits package
- Professional development opportunities
- Flexible work arrangements
Qualifications:
- Bachelor's degree in a relevant scientific discipline; advanced degree (PhD, MD, or equivalent) preferred
- Minimum 10 years of experience in regulatory affairs, with specific experience in oncology drug development
- Proven track record of leading successful regulatory submissions and interactions with regulatory agencies
- Deep understanding of FDA regulations and international regulatory requirements
