Regulatory Affiars Associate (CMC)

Job Summary

As a Regulatory Affairs Associate, you will be responsible for managing the day-to-day chemistry, manufacturing, controls (CMC) regulatory activities for all assigned marketed products. You will be responsible for compiling, organizing, and assessing documents for regulatory submissions to USFDA. Also, you will be responsible for post approval compliance including annual reports, supplements, labeling, and other product related correspondences to regulatory authority for approved drug products.

*This is a US-Based position that requires 100% on site work*

JOB DUTIES & RESPONSIBILITIES include but not limited to:

• Draft, review, and submit post approval submissions such as annual reports, supplements, and other product related correspondences within the established timelines.
• Draft and review of CMC controlled documentation including but not limited to standard operating procedures, batch records, protocols, specifications, analytical test methods, and reports.
• Timely review and approve change controls related to filing documentation.
• Prioritize and independently complete assigned workload.
• Track and submit labeling updates within the regulatory timeframe.
• Represents the regulatory department and assists in the development of regulatory strategies.
• Interacts with CFTs to obtain documentation required for post approval submissions.
• Keep current with FDA regulations to ensure compliance with post-marketing requirements.
• Prepare and circulate FDA approval package to the responsible teams to ensure dossier compliance.
• Responsible for compendial updates implementation.
• Prepare and maintain the internal Regulatory Databases.

OTHER or ADDITIONAL RESPONSIBILITIES

• Perform other duties as assigned.

Reports to

Senior Manager, Regulatory Affairs

Reqiured Knowledge & Skills

• Familiar with FDA regulatory guidelines specifically chemistry, manufacturing, controls (CMC).
• Experience with eCTD regulatory filings.
• Ability to handle multiple projects concurrently.
• Ability to assess technical quality of documents and provide regulatory feedback to colleagues.
• Ability to quickly become proficient with internal regulatory systems.
• Ability to establish and maintain good working relationships with cross functional teams.
• Clear verbal and written communication skills.
• Proficiency in Microsoft Office, Adobe, and eCTD related tools.

Minimum Experience & Education

• Bachelor’s degree in Regulatory Affairs, Pharmaceutical Sciences, or related discipline with minimum 1-3 years of RA/QA experience in pharmaceutical industry OR
• Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, or related discipline with minimum 0-1 years of RA/QA experience in pharmaceutical industry

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.