Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)
Merck, Little Rock, AR, United States
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. The role supports multiple product portfolios and stages, including small molecules, biologics, vaccines, and drug product life cycle phases.
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.
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 for 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.
Identify, communicate and elevate potential issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs Leadership.
Apply understanding of regulatory affairs to ensure approval, product launch and maintenance of market supply worldwide.
Conduct all activities with a focus on compliance, training, and staying current on regulatory requirements.
Perform assignments with 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 technical arguments.
Strong oral and written communication skills with succinct and logical presentation.
Understanding of manufacturing, analytical and quality assurance processes.
Leadership Skills
Generate innovative solutions to complex regulatory problems and collaborate with key stakeholders.
Flexibility in responding to changing priorities or unexpected events.
Effective leadership, communication, interpersonal and negotiation with cross‑functional partners and health authorities.
Education
B.S. in a biological science, engineering, or related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biomedical Engineering, Biology, Microbiology, or Biochemistry.
Experience and Requirements
10 years of relevant experience in biological/pharmaceutical research, manufacturing, testing or regulatory CMC for candidates with a Bachelor’s; 5 years for Ph.D. holders.
Preferred Qualifications
Ability to critically review detailed scientific information and assess technical claims.
Scientific curiosity and commitment to continuous learning.
Technical leadership and understanding of chemical and pharmaceutical operations.
Innovative problem‑solving and flexibility to changing priorities.
Strong collaboration, decision‑making and critical thinking under pressure.
Excellent verbal, written, 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 documentation in medical devices or combination products.
Knowledge of design controls processes.
Preferred fields of study include Biology, Biochemistry, Chemistry, or Engineering.
Required Skills
Adaptability, audit compliance, change management, confidentiality, cross‑cultural awareness, data integrity, decision making, employee training programs, leadership, life cycle support, regulatory CMC, regulatory communications, regulatory compliance, regulatory experience, technical writing.
Preferred Skills
Drug product manufacturing, medical devices.
Salary & Benefits $190,800 – $300,300 per year. Eligible for annual bonus and long‑term incentive where applicable. Comprehensive benefits package includes medical, dental, vision, health care, retirement 401(k), paid holidays, vacation, and compassionate and sick days. Additional details available at the company benefits portal.
Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities for all applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information, visit the EEOC Know Your Rights resources.
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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.
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 for 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.
Identify, communicate and elevate potential issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs Leadership.
Apply understanding of regulatory affairs to ensure approval, product launch and maintenance of market supply worldwide.
Conduct all activities with a focus on compliance, training, and staying current on regulatory requirements.
Perform assignments with 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 technical arguments.
Strong oral and written communication skills with succinct and logical presentation.
Understanding of manufacturing, analytical and quality assurance processes.
Leadership Skills
Generate innovative solutions to complex regulatory problems and collaborate with key stakeholders.
Flexibility in responding to changing priorities or unexpected events.
Effective leadership, communication, interpersonal and negotiation with cross‑functional partners and health authorities.
Education
B.S. in a biological science, engineering, or related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biomedical Engineering, Biology, Microbiology, or Biochemistry.
Experience and Requirements
10 years of relevant experience in biological/pharmaceutical research, manufacturing, testing or regulatory CMC for candidates with a Bachelor’s; 5 years for Ph.D. holders.
Preferred Qualifications
Ability to critically review detailed scientific information and assess technical claims.
Scientific curiosity and commitment to continuous learning.
Technical leadership and understanding of chemical and pharmaceutical operations.
Innovative problem‑solving and flexibility to changing priorities.
Strong collaboration, decision‑making and critical thinking under pressure.
Excellent verbal, written, 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 documentation in medical devices or combination products.
Knowledge of design controls processes.
Preferred fields of study include Biology, Biochemistry, Chemistry, or Engineering.
Required Skills
Adaptability, audit compliance, change management, confidentiality, cross‑cultural awareness, data integrity, decision making, employee training programs, leadership, life cycle support, regulatory CMC, regulatory communications, regulatory compliance, regulatory experience, technical writing.
Preferred Skills
Drug product manufacturing, medical devices.
Salary & Benefits $190,800 – $300,300 per year. Eligible for annual bonus and long‑term incentive where applicable. Comprehensive benefits package includes medical, dental, vision, health care, retirement 401(k), paid holidays, vacation, and compassionate and sick days. Additional details available at the company benefits portal.
Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities for all applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information, visit the EEOC Know Your Rights resources.
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