Senior Specialist, Regulatory

Job Description

Position Summary:

Responsible for regulatory compliance as it relates to contract manufacturing and analytical services. Responsible for the coordination and evaluation of regulatory activities. Perform various activities for CMC authoring and review in support of client filings. Consult with clients on regulatory topics and support regulatory inspections from health authorities. Other responsibilities include providing letters of authorization to clients for referencing KBI biopharma's facility DMF, compiling and updating Site Master Files (Facility Drug Master File Documents), and annual updates to facility registrations.

Position Responsibilities:

• Lead CMC writing and review for Sponsors, utilize internal resources as needed to draft, review, and edit CMC sections of Sponsor's filings.
• Maintain all Regulatory Documentation to include LOA, Compliance Letters, Permits, and update all RA Share Points and Databases.
• Interact with Clients and Agencies regarding Regulatory Topics.
• Work with our publishing vendor to publish all RA documents to the appropriate agencies and within specified timeframes.

Minimum Requirements:

Relevant degree and minimum 3 years relevant work experience in biologics pharmaceuticals, other health regulated industry or experience working for a health authority

Experience with FDA, EMA, and knowledge of regulatory requirements with emphasis on regulatory requirements for biotechnology derived products. also requires a demonstrated track record in the following key areas:

• Strong orientation for attention to detail, regulatory compliance, and customer service
• Excellent writing and verbal communication skills
• Demonstrated level of respect for individuals
• Demonstrated contribution to science in appropriate area
• High level of integrity and personal responsibility
• Record of innovation
• Strong collaboration and team building skills
• Independent project leadership.

Salary: $77,597.00-$106,696.00

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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