CMC Regulatory Affairs Associate (eCTD Module 3)

Local Candaits only

Bachelor’s Degree: Science

Regulatory submission documentation creation background

3 open roles long term roles going up till 2026 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

Summary

• 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.

Duties

• 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: $32.00 - $34.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

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

Work Location: In person

Salary : $32 - $34