12 Month Term Position
Emergent BioSolutions is currently seeking a Sr Specialist for our Regulatory Affairs Department. The successful candidate will have 5 years of Regulatory Affairs experience in pharmaceutical/biological/vaccine product development and completed a B.Sc. Must have strong written and verbal communication skills, have strong interpersonal skills and the ability to build networks. Experience in document database management, electronic submissions is preferred. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.
Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.
As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.
We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.
The Regulatory Affairs Senior Specialist will prepare regulatory submission packages to the FDA, Health Canada, EU and/or other jurisdictions as required. Assigned work may include supporting investigational drug development programs, commercial product/establishment license preparation and maintenance, regulatory inspection support, safety reporting, development and/or control of product information and labelling. The Regulatory Affairs Senior Specialist will coordinate with Regulatory Operations to ensure timely submissions and maintain electronic document archives.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Lead the preparation and maintenance of regulatory submissions or a section of a major submission (license application) 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 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:
- 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 MSWord 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)
- Citizenship/Permanent Resident or Valid Work Permit.
- Successful Completion of a Criminal Record Check.
Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!