Sr Specialist, Regulatory Operations

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.

Emergent BioSolutions is seeking a technology-oriented candidate who is ready to engage with multiple cross functional and global groups utilizing new and existing technologies to streamline and harmonize global processes
Those who join Emergent BioSolutions feel a sense of ownership about their future and will excel in an environment characterized by respect, innovation and growth opportunities. Here, the candidate will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
The candidate will work within a global team to provide support and guidance on various on-going submissions in order to retain compliance with all U.S. and international regulatory requirements under the oversight of the Senior Manager, Regulatory Operations.

Essential Functions

• 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
• Mentor and train other members of the Regulatory Operations Publishing team
• Participate in the identification and implementation of:
  • System upgrades and enhancements to meet the requirements of the evolving electronic submissions landscape.
  • Process improvement initiatives to improve Regulatory user experience and efficiency
• Assist Regulatory Affairs staff in the planning and preparation of submissions to regulatory agencies from the pre-IND stage through the final marketing application and post-approval support phase
• Represent Regulatory Operations on various teams and projects and report progress and learning to the other Regulatory Operations team members.

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
• [Register to View] or B.A. or a college diploma program with specialized training in Regulatory Affairs
• Minimum of 5+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.

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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 [Register to View] .

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.