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Sr Specialist, Regulatory Affairs

Location: 

Gaithersburg, MD, US, 20879


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 Senior Specialist will prepare regulatory submission packages to FDA, Health Canada, EU and/or other jurisdictions as required. Assigned will include supporting investigational drug development programs, safety reporting, development and/or control of product information and labelling and provide RA representation at project team meetings. The Regulatory Affairs Senior Specialist will coordinate with Regulatory Operations to ensure timely submissions and maintain electronic document archives.

 

Essential Functions 

•    Lead the preparation and maintenance of regulatory submissions or a section of a major submission in accordance with health authority requirements and Emergent procedures
•    Interact with manufacturing, clinical, nonclinical, product development and other departments to compile regulatory submissions
•    Participate on project teams as regulatory representative 
•    Develop regulatory plans for straightforward projects
•    Conduct and analyze regulatory guidance and information for well-defined projects
•    Solves routine problems with minimal assistance
•    Provide critical review of technical and scientific data to ensure regulatory compliance; begin to identify potential risks in submissions
•    Assist in the planning, coordination and preparation for meetings and teleconferences with regulatory agencies
•    Work closely with Regulatory Operations for timely submission of regulatory documents
•    Assist in the development of new labeling for assigned projects; review routine labeling changes
•    Communicate with regulatory agencies on administrative and routine matters or to address questions on specific submissions 
•    Participates in evaluating dossier management processes, identifying and sharing best practices with an end goal of continuous improvement and driving efficiencies.  May act as SME for specific processes that support entire department
•    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

•    5 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, MAA)

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Washington DC