Specialist, Regulatory Affairs

Location
Gaithersburg, MD, US
Posted
Feb 18, 2021
Ref
706457500
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

Job Summary

The Regulatory Affairs Specialist will assist in the in the preparation of regulatory submission packages to FDA and other jurisdictions as required. Assigned work will include supporting investigational vaccine development programs, 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

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• 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 nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum 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)

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 values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable 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.

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