Regulatory Affairs Associate I

Pay

Target pay range: $20‑30 per hour, depending on experience.

Responsibilities

• Manage activities for marketed product variations, including authoring and compiling chemistry, manufacturing, and control (CMC) sections.
• Coordinate activities with all functional departments to support regulatory filings.
• Manage, compile, and author CMC sections of marketed product variations, ensuring CTD content, structural, and formatting requirements are met.
• Oversee assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Facilitate project team meetings independently.
• Partner with Regulatory Affairs (RA) CMC Project Leads to develop Module 3 content and project timelines.
• Collaborate with diverse functional groups to ensure file‑ability and acceptance of CMC sections.
• Run review meetings for submission documents and maintain awareness of best practices for regulatory business systems.
• File necessary applications and handle all government interactions for products requiring approval.
• Author and submit PMA supplements (30‑day Notice, Real‑Time Reviews, 180‑Day Supplements, Annual Reports).
• Review and approve engineering study protocols/reports and validation study protocols/reports.
• Review and approve manufacturing changes for Class III implantable medical devices.
• May lead and direct the work of others, exercising creativity and latitude in task execution.

Requirements

• Bachelor’s degree (BA/BS) in Chemical, Biological Sciences, or a related discipline.
• 1‑2 years of pharmaceutical experience.
• 1‑2 years of cross‑functional project management experience.
• Familiarity with U.S. and international regulatory requirements for dossiers.
• May require an advanced degree and 1‑3 years of direct experience for Class III implantable device work.
• Recent experience with Class III implantable medical devices.
• Proven track record of authoring, submitting, and obtaining approval for Class III implantable PMA supplements.
• Knowledge of FDA PMA guidance documents and CFR regulations.

Skills

• Superior oral and written communication abilities.
• Ability to work cooperatively with global personnel at all levels.
• Experience with electronic document management systems.
• Strong independent work ethic and ability to manage multiple projects simultaneously.
• Detail‑oriented, accuracy‑focused, collaborative, and eager to learn.
• Skills for running review meetings for submission documents.
• Understanding of CMC expectations, including CTD content, structural, and formatting requirements.
• Maintains awareness of current best practices for regulatory business systems.