Assess CMC variations/changes through change control process.

Author and review ANDA, IND, NDA, and associated amendments and post approval supplements (CBEs, Annual Reports, etc.)

Ability to manage labeling operations (understanding of OTC labeling rules a plus).

Assure submissions adhere to FDA and ICH guidelines.

Assure submission process and standards adhere to company's SOPs.

Interact with clients regarding regulatory issues.

Conduct regulatory reviews for submission requirements.

Contribute to company initiated project teams in fulfilling corporate objectives as determined by RA management.

Mentor and develop regulatory associates.

Bachelor's Degree in a scientific discipline.

At least 3-5 years related industry experience.

Must have a good understanding of submission compilation and application requirements, applicable regulations.

Must have good verbal and written communication skills and interpersonal skills.

Must have the ability to manage multiple projects simultaneously.

Experience authoring complete ANDAs.

Knowledge of NDA submissions is a plus.

Labeling experience required.

Experience with ADE reporting is a plus.