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Regulatory Specialist
$1,000 SIGN-ON BONUS
Verona, WI
Job Description
POSITION OVERVIEW:
The primary role of the Regulatory Specialist position is to compile, review, and transmit eCTD submissions to the FDA. Maintain indices, records, and processes for all regulatory applications. Maintain annual GDUFA notification and updates. Provide regulatory support to project managers/scientists and clients to ensure compliance with FDA and international guidance. We are currently paying a $1,000 sign-on bonus to new employees after they have completed one year of service at CPI.
ESSENTIAL JOB FUNCTIONS:
- Apply for all necessary approvals and marketing permits from the FDA as well as international regulatory offices, and track, obtain, and renew any required permits, licenses, and registrations.
- Preparation of CMC regulatory documents for NDAs and DMFs including amendments, supplements, annual reports, and responses to the regulatory agencies.
- Prepare responses to questions and/or concerns from regulatory agencies within the timeframes specified.
- Maintain regulatory timelines and track deliverables to ensure regulatory submission timelines are met.
- Coordinate with CPI's functional areas and external support (e.g., contract laboratories) to request and obtain data relevant to submissions.
- Ensure all documentation for submission complies with pertinent regulations, company SOPs, and federal and international regulatory guidelines (e.g., ICH and GMP).
- Participate in the change control process and contribute to decisions regarding submission mechanism and documentation requirements to support proposed changes.
- Provide critical review of documents (SOPs, protocols, and reports), as necessary.
- Coordinate and provide client and project managers/scientists support on NDA, ANDA, and CMC section filings and facilitate drug research and interpret and report data to regulatory agencies.
- Interface with R&D on a regular basis to ensure project-specific regulatory strategy is met. Continually assess the product development process and reports and provide feedback to R&D on the projects assigned.
- Continually monitor newly published FDA guidelines and international guidance documents and provide training on applicable requirements for staff, as required.
- Performs GDUFA site and DMF registrations and other federal and international registrations.
- Resolves complex regulatory challenges by using creative and flexible thinking.
- Participate in Quality Systems improvement projects.
- Author required regulatory statements.
- Maintains compliance with all company policies, plans, and procedures, including safety, security, and regulatory.
- Other duties as assigned.
EDUCATION/SKILLS/KNOWLEDGE REQUIRED:
- BA/BS degree in life or physical sciences (e.g., Pharmaceutical Sciences, Chemistry, Analytical or other relevant disciplines).
- Minimum 3 years experience in Regulatory Affairs.
- 3+ years of experience in a FDA and cGMP environment. Experience in a cGMP pharmaceutical environment preferred.
- Environmental, Health, and Safety Knowledge, a plus.
- In-depth understanding of FDA 21 CFR regulations, ICH Guidelines, EU and Canadian GMPs.
- Proficient in Mirosoft Word, Excel, SharePoint, and Acrobat Professional.
- Outstanding written, verbal, and interpersonal communication skills required.
- Strong attention to detail.
- Ability to work independently and in a team.
- Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.
Job Summary
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40+
Work Hours (i.e. shift)
8AM - 4:30PM
Salary and Benefits
Based On Experience
Required Education
Bachelor's Degree
Required Experience
3+ years
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