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VP, Regulatory Affairs

Company: Emergent BioSolutions
Location: Gaithersburg
Posted on: July 15, 2019

Job Description:

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 Vice President, Regulatory Affairs, will provide leadership and oversee regulatory activities for Emergent's Vaccines and Anti-Infectives Business unit. This includes providing strategic as well as operational leadership and for managing the personnel and activities of the regulatory affairs team. The VP, RA will ensure development and execution of global regulatory strategies and submission plans. The VP, RA will ensure compliance with regulatory requirements for licensed products and products under development

Responsibilities



  • Manage a team of regulatory professionals located at various Emergent sitesDevelop and execute regulatory strategy, US and global, for Vaccines and Anti-Infectives products
  • Provide regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products
  • Direct efforts for Planning and execution of required regulatory filings
  • Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
  • Prepare company team for FDA and other health authority meetings
  • Ensure oversight and manage RA department interface with the FDA and other regulatory authorities in an optimal manner
  • Represent Regulatory Affairs on the business unit leadership team and at cross-functional teams
  • Manage preparation and communicate regulatory risk assessment to business unit team and senior management and propose mitigation approaches
  • Provide critical review of documentation supporting regulatory applications including, but not limited to, pre-IND and formal meetings with health authorities, INDs, Clinical Trial Applications, Annual Reports, BLAs, NDAs, MAAs, Variations and BLA supplements
  • Ensure progress for the assigned area of responsibility and provide routine progress update to functional and business unit management
  • Maintain knowledge of regulatory environment, regulations and guidances.
  • Monitor applicable current and new regulatory requirements and interact with company partners and consultants for various regulatory matters as needed
  • Contribute regulatory perspective as needed on government proposals and external due diligence activities
  • Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs

    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



    • PhD or Master's Degree w/ equivalent relevant experience required.
    • 15+ years of industry experience in Regulatory Affairs for biological products in product development and post licensure settings.
    • Knowledge of global regulations / guidances and thorough knowledge of biological (Vaccines)/ drug development process required. knowledge of small molecule regulations desired
    • ---Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.
    • Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC, clinical and non-clinical pharmaceutical development,
    • Possess a broad knowledge of biopharmaceutical manufacturing and operations.
    • Experience with international regulatory submissions preferred.

      Physical/Mental Requirements

      Type/keyboard, visual acuity, Good eye/hand coordination, sit, hand dexterity, sense of hearing. Use phone, fax, copier, and computer. Able to organize/ coordinate, analyze/ interpret, problem-solve, make decisions, plan, communicate, and prepare written communications.

      Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.

Keywords: Emergent BioSolutions, Washington DC , VP, Regulatory Affairs, Executive , Gaithersburg, DC

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