Partners for Regulatory Compliance, Business Development, Toxicology Studies in Rockville

Job DescriptionAbout MBC Life Sciences

MBC Life Sciences is a life-sciences consulting, advisory and service firm focused on helping pharmaceutical and life-sciences companies build capabilities, strengthen regulatory and quality compliance, and connect with opportunities across global markets.

Building & Connecting Life Sciences | Enabling Global Growth

Our work is focused particularly on supporting companies involved in pharmaceutical drug development, manufacturing, quality systems, regulatory compliance, and expansion into the U.S. market.

MBC Life Sciences is developing a network of experienced subject-matter experts and industry professionals who can work with us on a project-by-project, independent contractor basis.

Regulatory Compliance & FDA Consultant — Project-Based Contractor

MBC Life Sciences is seeking experienced regulatory and pharmaceutical compliance professionals to collaborate with us on a project basis.

We are particularly interested in professionals with substantial experience in pharmaceutical drug development, manufacturing, GMP/CGMP compliance, quality systems, and FDA inspections/audits.

This is not a full-time employment position. We are seeking experienced professionals who are interested in working with MBC Life Sciences as independent consultants/contractors when their expertise aligns with specific client projects.

Areas of Expertise

The ideal consultant will have experience in one or more of the following:

• Pharmaceutical regulatory compliance and regulatory strategy
• Drug development and regulatory requirements
• Pharmaceutical manufacturing and CGMP compliance
• Quality systems and pharmaceutical quality management
• FDA inspection readiness and inspection management
• Experience directly supporting or participating in FDA inspections
• Preparation for and response to FDA Form 483 observations
• CAPA, deviation, investigation, change control, and related quality-system activities
• Internal and supplier audits
• Quality risk management and compliance assessments
• Remediation of regulatory or quality-system deficiencies
• Regulatory compliance assessments of pharmaceutical manufacturing facilities
• Experience working with U.S. FDA requirements and pharmaceutical companies seeking access to the U.S. market

FDA inspections evaluate pharmaceutical manufacturers against applicable CGMP requirements, including manufacturing processes, facilities, controls, quality systems, records, and related areas.

Qualifications

We are looking for professionals who have:

• Several years of relevant pharmaceutical industry experience
• Strong knowledge of U.S. FDA regulations and pharmaceutical CGMP requirements
• Demonstrated experience in pharmaceutical drug development and/or manufacturing
• Direct experience with FDA inspections/audits strongly
• Experience preparing organizations for FDA inspections and responding to inspection findings
• Strong understanding of pharmaceutical quality systems
• Experience working with pharmaceutical manufacturers, CDMOs, biotech companies, or related organizations
• Strong analytical, communication, and problem-solving skills
• Ability to work independently and interact professionally with clients
• Consulting, advisory, or project-based experience is a plus

Engagement Model

• Independent contractor / project-based
• Engagements will depend on client requirements and project scope
• Flexible involvement based on the consultant's expertise and availability
• Opportunities may include short-term assessments as well as longer consulting engagements
• Compensation will be discussed based on experience, expertise, project scope, and level of involvement

Who We Would Like to Hear From

We welcome experienced pharmaceutical regulatory, quality, compliance, manufacturing, and FDA inspection professionals who are interested in becoming part of a flexible network of subject-matter experts supporting pharmaceutical and life-sciences clients.

If you have significant pharmaceutical regulatory or quality experience and would be interested in collaborating with MBC Life Sciences on future projects, we would like to hear from you.