Katalyst CRO
Responsibilities
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- 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.
- Skills for running review meetings for submission documents.
- Understand CMC expectations including CTD content, structural and formatting requirements.
- Maintain awareness of and utilize 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.
- 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.
- Independently facilitate project team meetings.
- Familiarity with US and other international regulatory requirements for dossiers.
- 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.
Requirements
- Minimum of a BA/BS Degree in Chemical, Biological Sciences, or relevant discipline.
- 3+ years pharmaceutical experience. 1-3 years cross-functional project management.
- 4 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3).
- May require an advanced degree and 2 to 5 years of direct experience in the field.
- Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
- Performs a variety of tasks.
- May lead and direct the work of others.
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