Pharma Market Strategy & Regulatory SME (Remote)

Flowserve

Texas

Remote

USD 150,000 - 190,000

Full time

10 days ago

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Job summary

Flowserve is seeking a Pharmaceutical Manufacturing and Regulatory Subject Matter Expert to lead market strategy and regulatory alignment across global pharma customers. This remote role requires deep knowledge of cGMP, regulatory expectations, and cross-functional collaboration with engineering, sales, and operations.

Ideal candidates have experience with health authorities and global regulations, a track record translating market needs into product priorities, and are located in Ireland with

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Business, or a related field.
  • Several years of experience in the pharmaceutical, biopharmaceutical, biotech, bioprocess, or regulated life-sciences industry.
  • Knowledge of FDA/EMA expectations and global pharmaceutical regulations.
  • Strong understanding of pharmaceutical manufacturing requirements and regulatory expectations.
  • Experience translating customer and market needs into product, commercial, or operational requirements.
  • Experience working cross-functionally.
  • Proven ability to engage credibly with technical and commercial stakeholders at pharmaceutical manufacturers, OEMs, system integrators, and other industry partners.
  • Fluent English and willingness to travel internationally.

Responsibilities

  • Voice of the Customer: translate requirements into actionable business and product priorities.
  • Regulatory Guidance: advise on expectations including cGMP, validation, supplier qualification, and change control.
  • Commercialization & Product Strategy: input to roadmaps and go-to-market plans.
  • Market Execution: develop targeted strategies for pharmaceutical applications.
  • Stakeholder Engagement: nurture relationships with manufacturers, OEMs, and partners.
  • Technical Evaluations: support trials, evaluations, and industry events.
  • Cross-Functional Go-to-Market: partner with Sales, Product Management, Engineering, Operations, Supply Chain, and Marketing.
  • Market & Competitive Intelligence: conduct analyses to identify opportunities.
  • Channel & OEM Development: support partner development and early design-in opportunities.
  • Executive Alignment: communicate priorities and risks to leadership.

Skills

Regulatory knowledge
Cross-functional collaboration
Stakeholder engagement
Market strategy
Communication skills
English fluency

Education

Bachelor's degree
Advanced degree preferred

Job description

Flowserve is seeking a Pharmaceutical Manufacturing and Regulatory Subject Matter Expert to lead market strategy and regulatory alignment across global pharma customers. This remote role requires deep knowledge of cGMP, regulatory expectations, and cross-functional collaboration with engineering, sales, and operations.

Ideal candidates have experience with health authorities and global regulations, a track record translating market needs into product priorities, and are located in Ireland with

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