Regulatory Affairs CMC Specialist

To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepakarya8a79aa22a/ ), email your updated resume at Email deepak.arya@collabera.com . Thank you!

Pay Range:

$25 to $30 an hour.

Client Industry:

Pharmaceutical Job Mode:

Hybrid (Onsite Tuesday, Wednesday, Thursday)

Contract Duration:

12 Months Contract (Potential Extension Based on Performance and Business Needs)

Job Summary:

We are seeking a Regulatory Affairs CMC Specialist to support regulatory submissions for marketed pharmaceutical products in a large enterprise environment. This role is responsible for authoring, compiling, and managing Chemistry Manufacturing and Controls documentation while coordinating with cross functional teams to ensure high quality regulatory submissions. The ideal candidate will manage multiple projects, maintain submission timelines, and ensure compliance with regulatory requirements. This position offers an opportunity to work closely with Regulatory Affairs, Manufacturing, Research and Development, and Quality teams in a collaborative environment.

Key Responsibilities:

Manage Chemistry Manufacturing and Controls documentation for marketed product variations. Author, compile, and review CTD Module 3 content for regulatory submissions. Coordinate activities across Regulatory Affairs, Manufacturing, Research and Development, Quality, and other functional teams. Develop and maintain submission timelines to ensure timely regulatory filings. Facilitate cross functional meetings to support submission preparation and document reviews. Ensure regulatory documents meet content, structure, formatting, and quality requirements. Manage responses to regulatory agency questions and requests for additional information. Maintain documentation within electronic document management systems. Monitor project priorities and adjust plans based on business needs. Remain current with regulatory guidance and industry best practices.

Required Qualifications:

Bachelor degree in Chemical Sciences, Biological Sciences, or a related scientific discipline. One to two years of pharmaceutical industry experience. One to two years of cross functional project management experience. Experience preparing or managing Chemistry Manufacturing and Controls documentation. Knowledge of CTD Module 3 content and regulatory submission requirements. Experience working with electronic document management systems. Excellent written and verbal communication skills. Strong organizational skills with the ability to manage multiple projects independently.

Preferred Qualifications:

Experience in Regulatory Affairs, Manufacturing, or Research and Development. Knowledge of international regulatory submission requirements. Experience with PMA supplements, annual reports, or regulatory agency interactions. Knowledge of FDA guidance documents and regulatory requirements. Experience supporting Class III implantable medical devices.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)