Director, Drug & Device Combo (AutoinjectorInhalation) 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 Companys autoinjector inhalation and other delivery system products in accordance with global regulations and guidelines and isresponsible for technical content input and coordination of CMC submissions for all assigned 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 Bachelors degree or Masters 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:

Preferred Skills:

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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 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

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 employees 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 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.

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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

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