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Join OPL

Grow With OPL Pharmaceuticals

We are looking for people who are driven by innovation, disciplined in execution, and determined to grow with the company while creating meaningful solutions for human health.

We Need People With These Attributes

  • Passion to develop new drug products
  • Perseverance in research and development
  • Courage to innovate new drug delivery technologies
  • Determination to grow and to succeed with the company
  • Self-motivation and responsibility for projects and for themselves

Why Join OPL

  • Work on differentiated pharmaceutical products with global potential
  • Collaborate across China and U.S. teams with strong technical resources
  • Take ownership in a fast-moving, execution-focused environment
  • Grow with a company committed to innovation, compliance, and commercialization

Available Positions

General Manager, US Operation

Report to CEO San Diego, USA

Job Description

  • Responsible to oversee operation of US site and ensure compliance with FDA GMP and DEA guideline.
  • Get business from US clients who need formulation development services.
  • Lead technical team and related departments to carry out oral solid formulation development and manufacturing work according to timeline and quality agreement.
  • Leverage resources from different sites of the company to meet client needs.

Qualifications

  • Master with 10 years of related work experience, or Ph.D. with 8 years of related work experience.
  • Experience recruiting talent and managing multiple departments.
  • Experience with oral solid formulation development and manufacture.
  • Good connections with professionals in the pharmaceutical industry.
  • Proven successful track record in business development.
  • Strong leadership, communication, and interpersonal skills.
  • Business acumen to drive business growth and self-sufficiency.
  • Fluent in English and Mandarin.

Manager, Clinical Operation

Report to COO Travel up to 30%

Job Description

  • Screen and select clinical CROs to conduct IIT, PK studies, and efficacy studies.
  • Communicate study objectives to clinical CROs and review clinical protocols.
  • Lead and oversee the execution of clinical trials.
  • Compile clinical results into NDA application dossier.

Qualifications

  • Master with 5 years of experience, or M.D. / Ph.D. with 5 years of experience.
  • Experience as a clinical operations professional with successful track record.
  • Strong communication, leadership, and interpersonal skills.
  • Strong academic background and deep understanding of clinical research methodologies, evidence-based medicine, and the healthcare industry.
  • Willing to travel up to 30%.

Manager, Global Regulatory Affair

Report to RA Director Global Regulatory

Job Description

  • Coordinate with different departments to acquire development reports including formulation, analytical, and clinical trial materials for NDA or ANDA submissions to agencies including US FDA, EU EMA, Japan PMDA, and China NMPA.
  • Communicate with regulatory agencies to inquire about approval progress, answer questions, and coordinate internal responses to deficiency letters.
  • Answer questions from internal teams and provide training on updates to regulatory guidelines.

Qualifications

  • 5 or more years of experience in the pharmaceutical industry dealing with regulatory issues.
  • Experience interacting with cFDA, FDA, EMA, or other government agencies preferred.
  • Strong knowledge of US and EMA regulatory requirements and legal framework for pharmaceutical products, as well as industry trends.
  • Self-motivated with demonstrated leadership skills and a record of achievement in area of responsibility.
  • Excellent communication, interpersonal, negotiation, and organizational skills.

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