Global Pharma Regulatory & Commercial Strategy Lead

Flowserve Corporation; Yorktown (VA); On-site; USD 173,000 - 260,000; Full time

Benefits offered by this job

Competitive Base Salary

Medical, Dental & Vision Insurance

401(k) Retirement Savings Plan with 1:

Paid Time Off and Holidays

Parental Leave

Life/AD&D Insurance

Global Career Mobility

Job summary

Flowserve Corporation seeks a Global Pharmaceutical Subject Matter Expert (SME) to lead regulatory alignment, technical credibility, and commercial strategy across expanding life sciences initiatives. You will translate biopharmaceutical standards into actionable commercial roadmaps and customer partnerships.

You will bridge bioprocess engineering, regulatory governance, and cross-functional teams, driving adoption of CIP/SIP, validation, and quality systems while expanding global pharmaceutical

Qualifications

• Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical), Life Sciences (Biochemistry, Biology, Pharmacology), Business, or a closely related discipline.
• 8+ years of industry experience across pharmaceutical manufacturing, bioprocess engineering, or life sciences quality/regulatory affairs.
• Substantial background working with or alongside a regulatory agency, health authority (e.g., FDA, EMA, MHRA), or senior regulatory-compliance/quality leadership role.
• In-depth expertise in cGMP regulations, ASME BPE standards, cleanroom classifications, CIP/SIP cycle dynamics, clean utilities, and validation lifecycles (IQ/OQ/PQ).
• Translate health authority guidance, regulatory compliance needs, and quality audit findings into commercial product requirements and operational practices.
• Exceptional communication, executive presentation, and cross-functional leadership skills with ability to influence globally.
• Willingness to travel globally up to 30%–40% for audits, integrations, trials, and events.
• Legally authorized to work in the United States without sponsorship.

Responsibilities

• Serve as the primary Voice of the Customer (VoC) translating biopharmaceutical requirements into engineering, operational, and commercial priorities.
• Provide expert regulatory guidance regarding health authority expectations, change control, documentation, supplier qualification, material traceability, and risk mitigation.
• Partner with Product Management and R&D to guide roadmaps, launch-readiness criteria, and commercialization strategies for sterile, sanitary, and bioprocess environments.
• Cultivate strategic relationships across global pharmaceutical manufacturers, bioprocess skid integrators, and industry groups.
• Spearhead market execution and account-penetration strategies in high-growth areas like cell/gene therapy, monoclonal antibodies, API synthesis, and bulk biologics.
• Support trials, pilot evaluations, reference installations, symposiums, and global industry roadshows.
• Collaborate with Global Sales, Marketing, and Supply Chain on value propositions, validation dossiers, and sales-enablement materials.
• Perform market surveillance, regulatory intelligence, and benchmarking to identify high-value accounts and partnerships.
• Present strategic initiatives and progress to executive leadership.

Skills

Regulatory affairs

cGMP compliance

Cross-functional leadership

Global market strategy

Education

Bachelor's degree in Engineering or Life Sciences

Advanced degree preferred

Tools

ISPE PDA

Job description

Flowserve Corporation seeks a Global Pharmaceutical Subject Matter Expert (SME) to lead regulatory alignment, technical credibility, and commercial strategy across expanding life sciences initiatives. You will translate biopharmaceutical standards into actionable commercial roadmaps and customer partnerships.

You will bridge bioprocess engineering, regulatory governance, and cross-functional teams, driving adoption of CIP/SIP, validation, and quality systems while expanding global pharmaceutical