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.
The Regulatory Affairs Senior Specialist will prepare regulatory submission packages to 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/PAS) 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/combination 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)
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.
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.