Global Pharma Regulatory & Commercial Strategy Lead

Flowserve Corporation; Maryland; On-site; USD 173,000 - 260,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental & vision insurance

Annual incentive bonus

Paid time off & holidays

Global career mobility

Job summary

Flowserve Corporation seeks an accomplished Global Pharmaceutical Subject Matter Expert (SME) to align regulatory, manufacturing credibility, and commercial strategy across life sciences initiatives. This global role translates cGMP and health authority expectations into actionable product roadmaps and customer partnerships.

Operating at the intersection of life sciences engineering and regulatory governance, you will bridge gaps between end users, bioprocess OEMs, skid builders, and Flowserve

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Business or related discipline.
• 8+ years in pharmaceutical manufacturing, bioprocess engineering, or life sciences regulatory affairs.
• Experience with regulatory agencies (FDA/EMA/MHRA) or leadership in regulatory/compliance within pharma.
• Deep knowledge of cGMP, ASME BPE, cleanroom classifications, CIP/SIP, IQ/OQ/PQ lifecycles.

Responsibilities

• Serve as primary VoC translating regulatory and quality needs into engineering, operational, and commercial priorities.
• Provide expert regulatory guidance on health authority expectations, change control, documentation, supplier qualification and risk mitigation.
• Guide product roadmaps, launch-readiness, and commercialization strategy for sterile and bioprocess environments.
• Develop strategic relationships with pharmaceutical manufacturers, bioprocess skid integrators, academia and industry groups.
• Lead market execution and account-penetration strategies in high-growth areas like cell/gene therapy and APIs.
• Support customer trials, pilot evaluations, reference installations, and global industry events.
• Collaborate with Global Sales, Marketing, and Supply Chain on differentiated value propositions and validation dossiers.
• Conduct regulatory intelligence and benchmarking to identify high-value accounts and OEM partnerships.
• Present strategic market initiatives and progress to executive leadership.

Skills

Regulatory leadership

Cross-functional leadership

Executive communication

cGMP & regulatory affairs

Education

Bachelor's degree in Engineering/Life Sciences

Advanced degree (MS/MBA/PhD)

Job description

Flowserve Corporation seeks an accomplished Global Pharmaceutical Subject Matter Expert (SME) to align regulatory, manufacturing credibility, and commercial strategy across life sciences initiatives. This global role translates cGMP and health authority expectations into actionable product roadmaps and customer partnerships.

Operating at the intersection of life sciences engineering and regulatory governance, you will bridge gaps between end users, bioprocess OEMs, skid builders, and Flowserve