Regulatory Affairs Manager/ Director (Remote)
Posted on: June 24, 2022
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!
- Ten + years of regulatory experience in pharmaceutical industry
- Bachelor's or Master's Degree in a scientific discipline or
- 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
- Knowledge of Windows based software programs such as Word,
- Familiarity with the FDA website is important in order to
accomplish daily tasks
- 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
- 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
- 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
- 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
- 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
- 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"
Keywords: Jobot, Cincinnati , Regulatory Affairs Manager/ Director (Remote), Executive , Cincinnati, Ohio
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