CMC Regulatory Affairs Associate (Module 3)

Location: North Chicago - Local and Hybrid required

Bachelor’s Degree: Science

Regulatory submission documentation creation background

Position is for Post approval changes CMC module 3 exp needed and must have More than 5-10 plus yrs of exp will also be considered

• Client is looking for some one with 1-5 yrs exp
• Solid CMC and CMC dossier background
• Proactive and self-starter
• Time management
• Able to work on multiple projects 5-6 projects)
• Communication skills
• CMC module 3 exp needed
• Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirement
• Post approval change management dossier group
• Bachelors degree needed
• Regulatory documentation exp needed
• Project on CMC side Module 3
• Submissions are global
• Manage timelines
• Able to work independently
• Multitasking
• Going across different groups across the company to get job done
• Some one who quickly picks up on technology and systems
• Team player
• Pharm D will also work

Contract: Through end of 2025 with possible extension - Based on performance and business needs

• Bachelors Degree: Science
• Regulatory submission documentation creation background

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)

RA Associate

• 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.

Job Type: Contract

Pay: $30.00 - $32.00 per hour

Expected hours: 40 per week

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• CMC regulatory affairs: 3 years (Preferred)
• CMC module 3: 3 years (Preferred)
• Regulatory submission documentation creation background: 3 years (Preferred)
• pharmaceutical industry: 3 years (Preferred)

Ability to Commute:

• North Chicago, IL 60064 (Required)

Work Location: In person

Salary : $30 - $32