Senior Manager, Regulatory Affairs, CMC at Delcath Systems Inc
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About This Position
We're excited to provide a complete benefits package, including a comprehensive health plan, 401(k), and professional development opportunities, to support the well-being and growth of our employees and their families.
POSITION SUMMARY
The Senior Manager, Regulatory Affairs, CMC is responsible for executing the day-to-day tactical activities of CMC regulatory submissions, with specific emphasis on compiling and submitting regulatory submissions. The Senior Manager, Regulatory Affairs shall provide direct regulatory submission support for NDA/IND for our oncologic drug/device combination product that is regulated as a drug.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
- Must be familiar with the Quality Systems Registration under 21 CFR 820, Regulation of Combination Products 21 CFR 4, and EU Medical Device Regulation (MDR).
- Must have knowledge of Investigational New Drug regulations under 21 CFR 312 and Applications for FDA Approval to Market a New Drug regulations under 21 CFR 314.
- Must have device product experience, drug/device combination product experience a plus.
- Must be familiar with FDA’s current thinking and guidance for industry.
- Execute day-to-day processes for regulatory accountabilities to ensure continual regulatory compliance with FDA and MDR requirements.
- Work closely with regulatory team and internal staff to prepare, review and submit international regulatory and domestic submissions. These shall include submissions for NDA, IND and CTA supplements and amendments thereof.
- Assist in the preparation, review, and submit annual reports, amendments and supplemental applications to INDs, NDAs, and CTAs.
- Monitor, review and interpret new or revised regulatory requirements and proactively advise corporate disciplines.
- Must be able to review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; and appropriately document the regulatory disposition of such changes.
- Other activities as assigned by management.
This position currently has no direct reports.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
- A BS or MS degree in physical or life sciences required.
- Must have at least 5 years drug regulatory affairs experience in the pharmaceutical industry, with direct accountabilities related to Health Authority submissions and compliance related matters.
- Must have direct working knowledge of FDA and International drug regulations.
- Experience working across multi-disciplinary levels, functions and regions is required.
- Must be team oriented, with the ability to work well with diverse cross-functional teams.
- Must possess strong analytical and process skills and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.
- Must possess strong verbal and written communication skills.
- Must be willing to travel.
LANGUAGE SKILLS
Must be able to read and interpret technical documents. Must be able to effectively write routine reports and correspondence. Must possess ability to speak effectively with employees and outside organization.
MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Job Location
Job Location
This job is located in the United States region.