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Specialist, Regulatory Affairs

Company: Emergent BioSolutions
Location: Lansing
Posted on: May 16, 2020

Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Regulatory Affairs Specialist will assist in the in the preparation of regulatory submission packages to FDA, Health Canada, EU and/or other jurisdictions as required. Assigned work may include supporting investigational drug development programs, commercial product/establishment license preparation and maintenance, regulatory inspection support, safety reporting, development and/or control of product information and labelling. The Regulatory Affairs Specialist will coordinate with Regulatory Operations to prepare submissions and maintain document archives.



Essential Functions (Include key responsiblities only. This should not be an all encompassing list)

* Assist in the preparation of regulatory submissions including pre-IND and formal meetings with FDA, INDs, BLAs, Annual Reports, and routine correspondence
* Provide critical review of technical and scientific data to ensure regulatory compliance
* Assist in the planning, coordination and preparation for meetings and teleconferences with regulatory agencies
* Interact with manufacturing, clinical research and nonclinical research, product development and other related departments to compile regulatory submissions
* Work closely with Regulatory Operations for timely submission of electronic and paper submissions
* Assist in the development of new labeling for assigned projects; review routine labeling changes and promotional materials for established products (as required)
* Prepare communication with regulatory agencies on administrative and routine matters as required
* Assis with the development of regulatory plans for well-defined projects
* Solves routine problems with input from line management
* Assist with the development of regulatory processes
* Participate on selected project teams as regulatory representative
* Participate in implementation of risk management plans for assigned projects.
* Other duties as assigned.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.



Education, Experience & Skills

* 2+ years of Regulatory Affairs experience preferred in pharmaceutical/biological/vaccine product development, but relevant work experience in pharmaceutical industry will be considered.
* B.Sc. degree required.
* Strong written and verbal communications.
* Strong interpersonal skills and ability to build networks
* Experience in document database management, electronic submissions preferred. Proficient in MS Word and other MS Office applications.
* Solves routine problems with input from line management
* Works within timelines and works with line management to set priorities
* Basic knowledge of US, Canadian and/or EU regulations and guidelines
* Basic understanding of drug development process
* Familiar with quality systems (GXPs)
* Experience in preparation of submissions (e.g. IND, BLA, CTA, NDS)



PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Keywords: Emergent BioSolutions, Lansing , Specialist, Regulatory Affairs, Other , Lansing, Michigan

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