Manager, Regulatory Affairs

Location
Gaithersburg, MD, US
Posted
Jun 03, 2021
Ref
720343900
Hotbed
BioCapital
Required Education
Bachelors Degree
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.

The Manager, Regulatory Affairs Document Management is responsible for managing all SOP's and BOP's for Global Regulatory Affairs. This includes the administrative oversight of the procedures and best practices, providing oversight of processes and coordinating necessary training. The position liaises with subject matter experts (SME's) to ensure technical content is accurate and provides any training or other administrative support in drafting, routing for approval, and effective dating of such procedures/practices. The position will also support RA Strategic Operations in analyzing data and critically evaluating systems and processes for harmonization and effectiveness (KPIs) and supporting process improvement initiatives.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Identify new concepts for analyzing data and promoting awareness of Regulatory Affairs strategies.
  • Understand and communicate impact of Industry and Agency changes relevant to RA and be a catalyst for innovative process change for improved efficiency.
  • Oversee the management of procedures and best practices; in consultation with SME's, draft procedures and best practices and ensure such documents are accurate and effective and are catalogued appropriately in the documentation system.
  • Assist the Regulatory Affairs team in training and educating team members on procedural changes.
  • Liaise with Operational Excellence team in applying OE Author and review internal work instructions and standard operating procedures (SOPs) pertaining to RA activities (electronic or paper), QC, and records management
  • Lead Regulatory initiatives aimed at improving internal regulatory standards, systems and procedures
  • Supports budgeting and forecasting activities, including possibly managing expenditure activities related to approved vendor contracts.
  • Support the organization with training needs; position will work with SME's to ensure proper training programs exist for technical areas but is not expected to be the SME trainer.
  • Collaborates with cross-functional teams to ensure overall process meets the needs of internal and external stakeholders

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
• Bachelor's degree or equivalent is required
• 5-10 years of experience preferred in Regulatory Affairs or Quality Assurance; manager experience preferred
• Experience in global submissions, document management, biological and vaccine products preferred.
• Previous experience with Operational Excellence initiatives
• Strong written and verbal communication skills.
• Strong interpersonal skills
• Careful attention to detail and accuracy required
• Extensive knowledge of MS Word, Project, PowerPoint, Excel, and other MS Office applications and Adobe Acrobat

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.

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