RA Manager

• Responsible for regulatory plans, submission, and approval of clinical trial and

marketing authorization applications i.e. compiling and reviewing IND and ANDA
documents to ensure compliance with international and regional regulatory
standards.

• Ensures all documents submitted to regulatory agencies are complete, well

organized, in regulatory compliance, and presented in manner that facilitates
agency review.

• Responsible for maintaining records of regulatory submissions and

communications with the relevant regulatory agencies.

• Coordinate with internal teams to ensure product compliance and registration

progress.

• Provide technical and regulatory expertise, assisting in resolving product

development an

• Manager projects with third party vendors and contractors to meet schedules and

ensure quality.

• Perform other duties as assigned.