Director, Drug & Device Combo; Autoinjector​/Inhalation Reg.-CMC; Remote

Job Description Director/Principal Scientist, Devices and Drug-Device Combinations Regulatory CMC

Reporting to the Director of Device Regulatory Affairs for Autoinjector Development Programs, the Director/Principal Scientist in Devices and Drug-Device Combinations CMC is responsible to support Device CMC regulatory activities for Our Company’s autoinjector, inhalation, and other delivery system products in accordance with global regulations and guidelines and is responsible for technical content input and coordination of CMC submissions for all assigned activities.

Product responsibilities may be in the small molecules, biologics or vaccines portfolio, and could be in the development or the marketed product phase of a drug product life cycle.

• Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.
• Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities.
• Lead technical content writing and review in autoinjector (other device)/integral combination product documentation including IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems.
• Identify, communicate, and elevate potential issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs Leadership
• Apply an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide.
• Conduct all activities with an unwavering focus on compliance, including staying current on all training.
• Carry out all assignments to the standards of efficiency, innovation, accuracy, and safety in accordance with company and regulatory requirements.
• Additional activities may be assigned by the supervisor.

• Demonstrated background in reviewing scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance).

• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
• Demonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authorities

• B.S. in a biological science, engineering, or a related field (advanced degree preferred).
• Fields of study include Pharmacy, Chemical Engineering, Biomedical Engineering, Biology, Microbiology, or Biochemistry

• 10 years relevant experience including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields for candidates with a Bachelor’s degree, or Master’s degree; minimum 5 years for candidates with a Ph.D. degree.

• The ideal candidate must have the ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data.
• They must demonstrate scientific curiosity, exemplified by a passion to continue to learn and by proactively identifying areas of self-development and growth .
• They should have technical leadership skills, as well as an understanding of related chemical and pharmaceutical operations (e.g., drug substance or drug product manufacturing, process development, analytical, quality assurance).
• The candidate must…