What are the responsibilities and job description for the Regulatory Affairs Associate position at Katalyst Healthcares & Life Sciences?
Responsibilities:
Requirements:
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- 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.
- 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.
- 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.
- 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
- 4 years pharmaceutical. 1-2 years cross functional project management
- 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
- May require an advanced degree and 3 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.
- Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.