Principal Regulatory Compliance Specialist

Job ID: | Position Type: Exempt, Regular, Full Time

location

Remote Position – Headquartered in San Francisco Bay Area  

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success.   We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

Duties:

As part of Pharmatech’s regulatory compliance consulting team, provide compliance services to clients in the regulated life science industry: pharmaceutical, biotech and medical device companies.

The primary responsibilities include supporting client sale initiatives as a technical expert within the organization:

  • Identify and engage potential new clients
  • Develop project proposals including staff and expense cost breakdowns
  • Work with clients to successfully complete the project approval process
  • Identify and secure appropriate project resources
  • Utilize industry network to grow Compliance sphere on a global basis

Execute best practices project management:

  • Leading a team of direct SME (Subject Matter Expert) reports within a project
  • Managing client personnel as required by project scopes of work
  • Ensuring adhering to project scope and processing change orders as needed
  • Producing communication tools for reporting project progress and completion reports
  • Identify opportunities to optimize client’s process technologies and improve quality
  •  Actively participate in the development and refinement of the Compliance sphere’s communication platform including: writing collateral, website content, white papers and trade journals
  •  Develop and deliver presentations to internal and external audiences of varying size • Select appropriate instruments and equipment from the laboratory through pilot plant and manufacturing scale-up

Qualifications:

  • BS. with a scientific or engineering related major is required
  • 10+ years of regulatory compliance work experience within the regulated life sciences industry
  •  Strong written and oral communications, strong project management skills, excellent technical writing skills
  • Expertise in GDP, cGMP’s. GLPs, ICH, CFR, and other major global regulations
  • A Working knowledge of new and emerging therapeutic technologies as they relate to quality and compliance requirements including: Antibody-Drug Conjugates (ADCs), Stem cells, Gene therapy, Personalized medicine, and mRNA therapeutics
  • Knowledge of DOE, QRM and QbD frameworks
  • Proficiency in Microsoft Business Suite
  • Must be motivated, able to work independently, and function in a team environment
  • Exceptionally motivated, detail oriented, and must be able to work independently with limited supervision
  • Ability to travel to and work remotely at client sites throughout the United States and internationally

 


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