PrismHR
Regulatory Manager | Quality Development Services (QDS)
Location:
Remote
Reports To:
Director of Regulatory Operations
The Opportunity: Lead Regulatory Excellence in Consumer Health
Are you a seasoned QA and Regulatory leader with a deep mastery of the OTC and Dietary Supplement landscapes? We are looking for a
Regulatory Manager
to serve as a high-level project owner and strategic advisor within our Quality Development Services team.
In this role, you will be the bridge between complex federal regulations and our clients’ commercial success. From FSMA compliance and HARPC planning to regulatory due diligence and formulation reviews, you will manage the full lifecycle of quality documentation. If you thrive in a project management-driven environment and possess the technical rigor to navigate FDA, FTC, and USDA standards, this is your opportunity to lead high-impact compliance initiatives.
What You Will Own & Execute
Regulatory Strategy & Submissions
Project Ownership:
Lead the preparation and submission of regulatory documentation for agencies and commercial partners, including SOPs, quality agreements, and professional opinions.
Compliance Reviews:
Conduct rigorous formulation reviews, marketing copy audits, and regulatory due diligence to ensure all products meet market-entry standards.
Safety & Standards:
Design and develop controlled documentation, including Safety Data Sheets (SDS), investigational reports, and study protocols.
Operations & Quality Control
FSMA/HARPC Leadership:
Write and review FSMA/HARPC plans and lead cGMP facility audits as directed.
System Optimization:
Maintain and control regulatory databases to ensure all files are audit-ready and compliant with national requirements.
Process Improvement:
Evaluate regulatory changes affecting client products and methodologies, providing proactive guidance on risk mitigation.
Advisory Services:
Provide leadership with strategic guidance on regulatory operations and compliance strategies.
Collaboration:
Operate seamlessly within a remote team using project management software to ensure traceability, accountability, and accurate billable time reporting.
Industry Engagement:
Represent the firm at tradeshows and conferences to maintain a pulse on industry trends and regulatory shifts.
What You Bring to the Team
Expert Credentials:
A BS in a scientific field is required; an MS or Ph.D. is highly preferred.
Industry Tenure:
A minimum of 12 years of Quality Assurance experience within the OTC industry. Additional experience in Dietary Supplements, Cosmetics, Food & Beverage, or Homeopathy is a significant bonus.
Regulatory Mastery:
Extensive, hands‑on knowledge of FDA, FTC, and USDA regulations, specifically CFR 21 Parts 11, 111, and 117.
Project Management Skills:
Proven ability to handle multiple complex projects simultaneously while maintaining extreme attention to detail.
Technical Proficiency:
Expert‑level skills in MS Teams, Word, Excel, and Adobe.
Why You’ll Love Working Here
Full Remote Flexibility:
Lead national projects from the comfort of your home office.
Health, Dental, and Vision insurance.
Generous Paid Time Off (PTO).
Strategic Impact:
Work at the forefront of regulatory operations, helping diverse clients navigate the complexities of the US market.
Professional Stature:
Represent a team known for scientific excellence and technical precision.
Schedule & Requirements
Type:
Full‑time.
Travel:
Travel as needed to client facilities or industry events (as permitted) to support project‑specific activities.
Compensation:
Target compensation is competitive and based on your depth of experience and credentials.
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Remote
Reports To:
Director of Regulatory Operations
The Opportunity: Lead Regulatory Excellence in Consumer Health
Are you a seasoned QA and Regulatory leader with a deep mastery of the OTC and Dietary Supplement landscapes? We are looking for a
Regulatory Manager
to serve as a high-level project owner and strategic advisor within our Quality Development Services team.
In this role, you will be the bridge between complex federal regulations and our clients’ commercial success. From FSMA compliance and HARPC planning to regulatory due diligence and formulation reviews, you will manage the full lifecycle of quality documentation. If you thrive in a project management-driven environment and possess the technical rigor to navigate FDA, FTC, and USDA standards, this is your opportunity to lead high-impact compliance initiatives.
What You Will Own & Execute
Regulatory Strategy & Submissions
Project Ownership:
Lead the preparation and submission of regulatory documentation for agencies and commercial partners, including SOPs, quality agreements, and professional opinions.
Compliance Reviews:
Conduct rigorous formulation reviews, marketing copy audits, and regulatory due diligence to ensure all products meet market-entry standards.
Safety & Standards:
Design and develop controlled documentation, including Safety Data Sheets (SDS), investigational reports, and study protocols.
Operations & Quality Control
FSMA/HARPC Leadership:
Write and review FSMA/HARPC plans and lead cGMP facility audits as directed.
System Optimization:
Maintain and control regulatory databases to ensure all files are audit-ready and compliant with national requirements.
Process Improvement:
Evaluate regulatory changes affecting client products and methodologies, providing proactive guidance on risk mitigation.
Advisory Services:
Provide leadership with strategic guidance on regulatory operations and compliance strategies.
Collaboration:
Operate seamlessly within a remote team using project management software to ensure traceability, accountability, and accurate billable time reporting.
Industry Engagement:
Represent the firm at tradeshows and conferences to maintain a pulse on industry trends and regulatory shifts.
What You Bring to the Team
Expert Credentials:
A BS in a scientific field is required; an MS or Ph.D. is highly preferred.
Industry Tenure:
A minimum of 12 years of Quality Assurance experience within the OTC industry. Additional experience in Dietary Supplements, Cosmetics, Food & Beverage, or Homeopathy is a significant bonus.
Regulatory Mastery:
Extensive, hands‑on knowledge of FDA, FTC, and USDA regulations, specifically CFR 21 Parts 11, 111, and 117.
Project Management Skills:
Proven ability to handle multiple complex projects simultaneously while maintaining extreme attention to detail.
Technical Proficiency:
Expert‑level skills in MS Teams, Word, Excel, and Adobe.
Why You’ll Love Working Here
Full Remote Flexibility:
Lead national projects from the comfort of your home office.
Health, Dental, and Vision insurance.
Generous Paid Time Off (PTO).
Strategic Impact:
Work at the forefront of regulatory operations, helping diverse clients navigate the complexities of the US market.
Professional Stature:
Represent a team known for scientific excellence and technical precision.
Schedule & Requirements
Type:
Full‑time.
Travel:
Travel as needed to client facilities or industry events (as permitted) to support project‑specific activities.
Compensation:
Target compensation is competitive and based on your depth of experience and credentials.
#J-18808-Ljbffr