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Regulatory Affairs Manager/ Director (Remote)

Company: Jobot
Location: Greenville
Posted on: May 14, 2022

Job Description:

100 % Remote

This Jobot Job is hosted by Juan Correa

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $150,000 - $250,000 per year

A Bit About Us

Over the years, we have observed how dramatically the microbiome can impact human health. We specialize in clinical studies that examine the mysteries of the microbiome for each individual tested. What bacteria are abundant? What bacteria are absent? What are the potential implications for overall health?

Why join us?

Competitive Base Salary!
Full Benefits!
Extremely Competitive Equity Package!
Flexible Work Schedules!
Accelerated Career Growth!

Job Details

Qualifications
Ten + years of regulatory experience in pharmaceutical industry is required
Bachelor's or Master's Degree in a scientific discipline or equivalent
Strong written and verbal communication skills necessary
Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
Ability to work effectively in a highly charged, fluid environment
Knowledge of Windows based software programs such as Word, Excel
Familiarity with the FDA website is important in order to accomplish daily tasks

Responsibilities
This position is responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions
In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests, and supporting other departments within the organization
Make consistent, sound regulatory assessments of proposed changes requested by operations or R&D
Responsible for preparation, compilation, review and submission of new NDAs, ANDAs, DMFs and INDs in eCTD format for FDA submission
Write related modules (Mod 1, Mod 2 and Mod 3) in CTD format for NDA, ANDA, DMF and IND
The submission content, style and architecture should adhere to electronic common technical document (eCTD) format
Follow current FDA and ICH guidelines and current cGMP and GLPs, pharmaceutical product testing requirements
Refer to USP requirements for chemical, physical and microbiological testing
Prepare, and submit INDs, NDAs, ANDAs, DMFs and ANADA annual reports, amendments and supplements in eCTD compliant format
Submissions should be prepared and reviewed for accuracy, consistency, and conformance to FDA and 21CFR regulations, ICH guidelines and in-house SOPs
Regulatory support of post-marketing commercial activities
Prepare and review supplements (PASs, CBE-30 and CBEs) for FDA submission
Review and approve change control forms for post approval activities of the product
Utilize regulatory and scientific skills to evaluate changes (such as changes to an approved product)
Evaluate prototype formulations for future filings based on IID database, RLD labeling, RLD patent(s) and exclusivities
Prepare Controlled Correspondences for FDA submission based on information provided by R&D department
The document should be prepared by utilizing scientific rational and supporting data provided by R&D department
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification
It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, Greenville , Regulatory Affairs Manager/ Director (Remote), Executive , Greenville, South Carolina

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