Job Description
Pharmaceutical Regulatory & Compliance Consultant Hiring Terms: Part-time
We are seeking a consultant on a
p art-time basis who can help us during presales and then during the implementation of
MetaPharma .
MetaPharma by MetaOption LLC is an integrated ERP solution designed specifically for the pharmaceutical industry.
Position Overview We are seeking a highly experienced
Pharmaceutical Regulatory & Compliance Consultant with deep expertise in U.S. FDA regulations, DEA requirements, and state-level compliance frameworks. The ideal candidate will have extensive experience in
pharmaceutical manufacturing and
wholesale distribution , ensuring operational excellence while maintaining strict adherence to regulatory standards.
Key Responsibilities - Regulatory Compliance Oversight
- Advise on FDA, DEA, and state regulatory requirements for pharmaceutical manufacturing and distribution.
- Develop and implement compliance strategies aligned with cGMP (Current Good Manufacturing Practices) and GDP (Good Distribution Practices) .
- Conduct internal audits, gap analyses, and risk assessments to ensure readiness for FDA inspections.
- Manufacturing & Distribution Support
- Provide guidance on facility design, validation, and operational workflows to meet compliance standards.
- Support wholesale distribution operations, including licensing, controlled substance handling, and supply chain integrity.
- Ensure compliance with serialization, track-and-trace, and DSCSA (Drug Supply Chain Security Act) requirements.
- Quality Systems & Documentation
- Establish and maintain SOPs, quality manuals, and compliance documentation.
- Train staff on regulatory requirements and best practices.
- Oversee corrective and preventive action (CAPA) programs.
- Strategic Advisory
- Advise leadership on regulatory trends, enforcement priorities, and compliance risks.
- Support product lifecycle management, including submissions, labeling, and post-market surveillance.
- Act as liaison with regulatory authorities during inspections and audits.
Qualifications - 5+ years of experience in the U.S. pharmaceutical industry, with a focus on manufacturing and wholesale distribution.
- Proven track record in FDA regulatory compliance , including cGMP, GDP, and DSCSA.
- Experience working with controlled substances and DEA compliance.
- Strong knowledge of pharmaceutical supply chain operations and quality systems.
- Excellent communication and advisory skills, with ability to train and mentor teams.
- Advanced degree in Pharmacy, Regulatory Affairs, Life Sciences, or related field preferred.
Desired Attributes - Analytical mindset with ability to identify compliance risks and propose practical solutions.
- Hands-on experience with audits, inspections, and remediation.
- Strategic thinker who can balance regulatory requirements with business objectives.
- Ability to work independently as a consultant and collaborate effectively with cross-functional teams.
Job Tags
Part time,