CMC Regulatory Affairs Associate (Module 3)

Description

Preference is Onsite - Lake County

Manager's Update:

This is an hybrid role (3 days onsite & 2)

• Prior exp. with Technical Files would be a plus
• Master's degree with internship kind of exp. would be considerable (But manager sounds like doubtful)
• Prior global exp. would be nice to have but not a deal breaker
• Prior medical device industry exp. would nice to have
• Operation & Submission exp. is not going to work in this role
• Prior analytical and process chemistry exp. would be helpful
• Must have a good communication skills
• ICH M4Q exp.
• Must have CTD/eCTD exp.
• Must have prior CMC exp.
• There is no overqualification in this role
• Minimum educational qualification: BS/MS
• Manager is looking for someone who can manage CMC
• Must have exp. with Module-3 on a CMC content
• Must have exp. with ICH module guidelines
• Manager is looking for 1-2 years of experience level within a regulated industry
• This position would be involve in Dossier preparation.
• Labeling focused person would not a good fit in this role
• Manager is open consider non-local candidate who can relocate at their own expenses || Currently 2-3 non-local persons are working within this team
• This team is not doing publishing. This team is only creating content for publishing
• Deal Breaking skills: CMC, Module-3, & CTD/eCTD content
• Must have prior pharma industry exp.
• Only med device would not work, the candidate have to have CMC and M-3 exp.

Length of Assignment: 6 months to start

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: 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) 

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.
• May require an advanced degree and 1-3 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 = 1-3 Years