Specialist, Regulatory Affairs

Location
Gaithersburg, MD
Posted
Jul 01, 2022
Ref
904312500
Hotbed
BioCapital
Required Education
High School or equivalent
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 Operations Specialist will be an integral member of the Global Regulatory Operations Team, providing support with various ongoing submissions in order to remain in compliance with all FDA and other U.S. and international regulatory requirements and company standards.  The qualified candidate will be responsible for supporting the compilation of regulatory submissions in eCTD format and providing support in the Emergent Regulatory Information Management System (RIM) under the oversight of the Senior Manager, Regulatory Operations.

 

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

 

The main duties and responsibilities include but are not limited to: 
•    Track and compile submission component documents from electronic sources; assemble, and publish submission documents in accordance with established timelines, global regulations, and relevant company procedures
•    Interact with internal regulatory staff and external vendors to facilitate on-time publishing and submission of regulatory documents
•    Assist in the development, implementation, and maintenance of document standards, templates, and procedures related to the formatting and publishing of electronic submissions and best practices in the Emergent RIMS. 
•    Assist in the ongoing maintenance of the Emergent RIMS by working with Regulatory Affairs team members to organize and update RIM Objects and metadata. 
•    Participate on project teams as Regulatory Operations representative
•    Support document migration as a part of potential company integration activities

 

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
•    B.Sc. or B.A. or a college diploma program with specialized training in Regulatory Affairs
•    Minimum of 3+years of experience in publishing global submissions for biological and vaccine products preferred.
•    Experience with DocuBridge submission publishing and Veeva document management preferred. Experience with other publishing and Regulatory Information Management systems will be considered.
•    Strong written and verbal communications. Strong interpersonal skills.  Ability to establish sound professional relationships. 
•    Ability to solve routine problems with minimal supervision
•    Ability to manage multiple submission publishing jobs effectively
•    Technical ability to understand data object associations and data flow. 
•    Careful attention to detail and accuracy required.

 

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment,  subject to legally required exemptions.

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.