Specialist, Regulatory Affairs Operations - Remote

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY 
The Regulatory Operations Specialist will be an integral member of the Global Regulatory Operations Team, providing support with various ongoing submissions 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 (or 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 regulatory submissions from electronic sources; assemble, and publish submission documents in accordance with established timelines, global regulations, and relevant company procedures
•    Review published submissions prior to filing to a Health Authority
•    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. 
•    Participate on project teams as Regulatory Operations representative
•    Support document migration as a part of potential company integration activities
•    Format MS Word documents that have been provided by Regulatory Affairs according to the Emergent Style and Formatting guide standards. 
•    Format PDF files to ensure that they meet company-defined standards for submission, such as PDF version, bookmarks, links, OCR, etc. 
•    Manage multiple requests, meeting all timelines, and ensuring all updates are captured

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 required, biological and vaccine products preferred.
•    Experience with DocuBridge submission publishing and Veeva document management preferred.  International publishing experience preferred.
•    Experience in Formatting documents in Microsoft Word
•    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.
 

If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $101,000 to $122,300]. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data.  The salary may also be adjusted based on applicant’s geographic location.  Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*.  Information regarding additional benefits can be found here:  https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.