Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)

MSD•Rahway, NJ

3d•Remote

About The Position

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. Primary responsibilities include, but are not limited to: Responsibilities: 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 escalate 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. Technical Skills: 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). Leadership Skills: 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 Education: 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 Required: 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. Preferred: 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 demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities. They must have superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role. The candidate must have excellent interpersonal, verbal, and written communication, presentation, and listening skills. Subject matter expertise in combination product regulatory development and manufacturing Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience in medical devices or combination products Strong knowledge and understanding of design controls process

Requirements

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.
Adaptability
Audits Compliance
Change Management
Confidentiality
Cross-Cultural Awareness
Data Integrity
Decision Making
Employee Training Programs
Leadership
Life Cycle Support
Pharmaceutical Process Development
Regulatory CMC
Regulatory Communications
Regulatory Compliance
Regulatory Experience
Technical Writing

Nice To Haves

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 demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities.
They must have superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.
The candidate must have excellent interpersonal, verbal, and written communication, presentation, and listening skills.
Subject matter expertise in combination product regulatory development and manufacturing
Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience in medical devices or combination products
Strong knowledge and understanding of design controls process
Preferred fields of study include Biology, Biochemistry, Chemistry, or Engineering
Drug Product Manufacturing
Medical Devices

Responsibilities

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 escalate 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.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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