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Manager Fda Consulting Jobs in Texas (NOW HIRING)

DHD Consulting

Deputy Project Manager

Austin, TX · On-site

Act as a liaison between clients, consultants, subcontractors, and internal teams to ensure clear ... Ensure full compliance with cGMP, FDA, ISPE, ASME BPE, and local building code standards throughout ...

CEDENT

Regulatory Affairs Consultant

Dallas, TX

Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs + Overview ... management standards such as ISO 13485 and FDA QSR (Quality System Regulations). Conduct gap ...

Spruce Infotech

SAP EWM Consultant

Dallas, TX · On-site

... Warehouse Management (EWM), including Advanced EWM capabilities, to act as Consulting Lead to ... Tailor EWM solutions to comply with Life Sciences GxP / validated environments including FDA / EMA ...

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Manager Fda Consulting information

What does a manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

How does a manager in FDA consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.

What are the key skills and qualifications needed to thrive as a manager in FDA consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily employed within companies managing regulatory submissions

While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.

What are the most commonly searched types of Fda Consulting jobs in Texas?

The most popular types of Fda Consulting jobs in Texas are:

What are popular job titles related to Manager Fda Consulting jobs in Texas?

For Manager Fda Consulting jobs in Texas, the most frequently searched job titles are:

What job categories do people searching Manager Fda Consulting jobs in Texas look for?

The top searched job categories for Manager Fda Consulting jobs in Texas are:

What cities in Texas are hiring for Manager Fda Consulting jobs?

Cities in Texas with the most Manager Fda Consulting job openings:

Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in Texas as of August 2026, with employment types broken down into 86% Full Time, 13% Part Time, and 1% Contract. Highlights an 84% Physical, 2% Hybrid, and 14% Remote job distribution.

Deputy Project Manager

DHD Consulting

Austin, TX • On-site

Full-time

Re-posted 5 days ago

Job description

Position Summary

We are seeking a seasoned Deputy Project Manager to help lead the construction of a large-scale biopharmaceutical manufacturing plant in Texas. In this critical leadership role, you will support the Project Manager across all project phasesfrom preconstruction to turnoverensuring technical execution, safety, compliance, and timely delivery. The role requires deep familiarity with GMP-regulated environments and proven experience managing complex, multidisciplinary construction projects.

Key Responsibilities

  • Assist in managing the full lifecycle of the project including planning, design coordination, construction, permitting, commissioning, and close-out.
  • Act as a liaison between clients, consultants, subcontractors, and internal teams to ensure clear communication and alignment.
  • Oversee day-to-day site activities, ensuring progress aligns with project timelines, budget goals, and quality standards.
  • Manage coordination among architectural, structural, and MEP trades, with specific emphasis on GMP systems like HVAC, WFI, PW, and CIP/SIP.
  • Ensure full compliance with cGMP, FDA, ISPE, ASME BPE, and local building code standards throughout all construction phases.
  • Conduct constructability reviews and lead technical reviews using AutoCAD, Revit, P&IDs, and BIM coordination tools.
  • Work closely with safety teams to ensure site adherence to OSHA and company-specific safety protocols.
  • Monitor project documentation including RFIs, submittals, change orders, and daily reporting.
  • Support procurement planning and vendor coordination to keep the project on track and under budget.
  • Prepare and deliver regular project updates to the Project Manager and stakeholders, highlighting risks and mitigation plans.

Required Qualifications

  • Bachelors degree in Engineering (Chemical, Mechanical, Electrical, Civil), Construction Management, Architecture, or a related discipline.
  • Minimum 20 years of construction experience, with at least 5 years focused on pharmaceutical or biopharmaceutical facilities.
  • Strong understanding of cleanroom systems, GMP utilities (WFI, PW, HVAC), and life science regulatory requirements.
  • Experience using construction coordination tools such as AutoCAD, Revit, and BIM platforms.
  • Skilled in project documentation, subcontractor management, and multidisciplinary team leadership.
  • OSHA 30-Hour Construction Safety Certification or willingness to obtain.

Preferred Qualifications

  • PMP, CM-Lean, or similar project management certification.
  • Experience navigating permitting, validation (IQ/OQ/PQ), and commissioning in bio-plant environments.
  • Previous experience on Texas-based construction projects.
  • Experience working with international teams and global EPC or construction firms.
  • Familiarity with FDA and EMA regulatory expectations for facility buildouts.

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