Regulatory Affairs Specialist

Harba Solutions Inc.; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Harba Solutions Inc. is seeking a Regulatory Affairs professional to manage end-to-end eCTD submissions, maintain regulatory documentation, and support FDA activities for marketed pharmaceutical products.

You will monitor FDA and international guidelines, draft labeling updates, and collaborate with Quality, Manufacturing, and Technical Operations to implement post-approval changes. A Bachelor's in a scientific field and 2+ years in Regulatory Affairs are required; RAC is a plus.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• 2+ years of Regulatory Affairs experience within the pharmaceutical industry.
• Experience preparing and submitting eCTD regulatory filings.
• Strong understanding of FDA regulations and CMC regulatory requirements.
• Experience supporting post-approval changes for commercial pharmaceutical products.
• Ability to manage multiple projects in a fast-paced GMP environment.
• Strong written and verbal communication skills.
• Experience working cross-functionally and leading regulatory initiatives.
• Proficiency with Microsoft Office and Adobe Acrobat.
• Experience with electronic document management systems and change control software.

Responsibilities

• Author, compile, review, and submit regulatory documents in eCTD format, including NDAs, ANDAs, DMFs, and post-approval submissions.
• Support FDA regulatory activities for marketed pharmaceutical products.
• Evaluate CMC regulatory impact of manufacturing and process changes.
• Develop regulatory strategies for post-approval changes and provide guidance to cross-functional teams.
• Prepare and review product labeling updates.
• Review regulatory documentation for completeness, accuracy, and compliance.
• Maintain regulatory databases and electronic document management systems.
• Monitor current FDA and international regulatory guidelines to ensure ongoing compliance.
• Support change control activities and regulatory documentation.
• Provide mentorship and guidance to junior regulatory professionals.
• Participate in project meetings and collaborate with Quality, Manufacturing, Technical Operations, and other functional groups.

Skills

Regulatory affairs

eCTD submissions

FDA regulations

Cross-functional leadership

Communication skills

Education

Bachelor's degree in a scientific discipline

Tools

Document management

Change control software

Microsoft Office

Adobe Acrobat

Job description

Key Responsibilities

• Author, compile, review, and submit regulatory documents in eCTD format, including NDAs, ANDAs, DMFs, and post-approval submissions.
• Support FDA regulatory activities for marketed pharmaceutical products.
• Evaluate CMC regulatory impact of manufacturing and process changes.
• Develop regulatory strategies for post-approval changes and provide guidance to cross-functional teams.
• Prepare and review product labeling updates.
• Review regulatory documentation for completeness, accuracy, and compliance.
• Maintain regulatory databases and electronic document management systems.
• Monitor current FDA and international regulatory guidelines to ensure ongoing compliance.
• Support change control activities and regulatory documentation.
• Provide mentorship and guidance to junior regulatory professionals.
• Participate in project meetings and collaborate with Quality, Manufacturing, Technical Operations, and other functional groups.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• 2+ years of Regulatory Affairs experience within the pharmaceutical industry.
• Experience preparing and submitting eCTD regulatory filings.
• Strong understanding of FDA regulations and CMC regulatory requirements.
• Experience supporting post-approval changes for commercial pharmaceutical products.
• Ability to manage multiple projects in a fast-paced GMP environment.
• Strong written and verbal communication skills.
• Experience working cross-functionally and leading regulatory initiatives.
• Proficiency with Microsoft Office and Adobe Acrobat.
• Experience with electronic document management systems and change control software.
• RAC certification is a plus.