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.-

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
• Preferred fields of study include Biology, Biochemistry, Chemistry, or Engineering

Required Skills:
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

Preferred Skills:
Drug Product Manufacturing, Medical Devices

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement•

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$190,800.00 - $300,300.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Remote

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
04/25/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R390822