Evaluate key strategic documents essential for NDA/MAA submission.
Develop and maintain clinical components of regulatory documents such as IMPD, IB, and IND.
Prepare for and participate in consultation meetings with regulatory bodies as necessary.
Assume primary responsibility for clinical sections in regulatory submissions to relevant regulatory agencies.
Provide oversight to clinical Regulatory Affairs consultants when required.
Monitor, interpret, and offer guidance on US and European regulations, guidelines, procedures, and policies pertinent to the company's activities.
Stay updated on regulatory intelligence.
Perform any other assigned duties as necessary.