CMC Regulatory Affairs Associate (Module 3)

Description

Lake County - Hybrid (3 days (Tue, Wed and Thur) onsite, Monday and Friday work from home).

Manager's Update:

• Must have CMC documentation exp.
• Needs to involve in Post approval changes
• Must have 2-4 years of exp. is required
• Must have ICH knowledge
• Must have CMC exp.
• Must have exp. with CTD/eCTD
• Authoring and Compilation of CMC document exp.
• PhD/Master's would not considered as overqualified in this role
• Prior project management exp./PMP Certification would be a great plus
• Minimum educational qualification: Bachelor's Degree
• Must have prior regulatory affairs background
• Must have exp. with Module-3 and Module-2
• Must have prior pharma industry exp.
• Must be a time management professional
• Prior process chemistry exp. would be helpful
• Needs to work with EDMS system (Manager would provide the training on EDMS before they start handling the actual roles and responsibilities)
• Module-3 is a deal breaking skill set the manager is looking for
• Prior medical device/Class III exp. would be a plus but not a deal breaker
  
  
• 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.
• 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
• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• Required Experience: 4 years pharmaceutical. 1-2 years cross functional project management
• Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
• 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.
• 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. May lead and direct the work of others.
• A wide degree of creativity and latitude is expected.

Experience Level = 3-5 Years