Regulatory Affairs Associate I

Position Overview:

Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activities with all functional departments in support of regulatory filings.

Responsibilities:

• Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and project timelines.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Skills for running review meetings for submission documents. Understand CMC expectations including CTD content, structural and formatting requirements.
• Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• Performs a variety of tasks.
• May lead and direct the work of others.

Skills:

• Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.

• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.

• Independently facilitate project team meetings.

• Superior oral and written communication skills

• Ability to work cooperatively with all levels and types of global personnel required

• Experience working with electronic document management systems

• Ability to work independently. Manage multiple projects simultaneously.

• Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.

• Detail/accuracy oriented, collaborative and willing to learn

• Familiarity with US and other international regulatory requirements for dossiers

Requirements:

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline

• Required Experience: 1-2 years pharmaceutical. 1-2 years cross functional project management

• Preferred Experience: 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)

• Recent experience with Class III implantable medical devices; knowledge of FDA PMA guidance documents and CFR regulations preferred.