WashingtonRecruiter Since 2001
the smart solution for Washington DC jobs

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


  • 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

HR Operations Manager
Description: Your Role: br br The Tenable Human Resources organization is seeking an HR Operations Manager who can support the company's strategic objectives through scaling and optimizing HR operations. This (more...)
Company: Tenable
Location: Columbia
Posted on: 07/18/2019

Air Force Account Manager (Remote) with Security Clearance
Description: ACCOUNT MANAGER OUTSIDE SALES br AIR FORCE Job Description If you re an enthusiastic and driven sales professional with a passion for technology and a desire to make a significant impact with an industry (more...)
Company: Force 3 LLC
Location: Crofton
Posted on: 07/18/2019

Psychiatric Medical Director
Description: Psychiatric-Mental Health opening in Baltimore, Maryland. This and other physician jobs brought
Company: FCSpsy
Location: Baltimore
Posted on: 07/18/2019

Catering Sales Manager
Description: DESCRIPTION br Crescent Hotels Resorts was built by operators for operators, and is more than just a portfolio of hotels. Crescent is part of an elite group of independent hotel management companies (more...)
Company: Baltimore Marriott Inner Harbor at Camden Yards
Location: Baltimore
Posted on: 07/18/2019

Senior Manager, Digital Product Development
Description: GENERAL SUMMARY: The Sr. Manager of Digital Product Management combines their expertise in user experience, student and prospect technology platforms, innovative thinking and agile process mastery to (more...)
Company: Laureate Education
Location: Columbia
Posted on: 07/18/2019

Senior Director, Enterprise Direct Sales
Description: Comcast brings together the best in media and technology. We drive innovation to create the world's best entertainment and online experiences. As a Fortune 50 leader, we set the pace in a variety of (more...)
Company: Comcast Corporation
Location: Greenbelt
Posted on: 07/18/2019

Restaurant Manager - Baltimore
Description: Position Overview: -- You may know us as a company with great food -- -- You may also know us from Fortune s 100 Best Companies to Work For list -------- -- What you may not know is that our menu is (more...)
Company: The Cheesecake Factory
Location: Baltimore
Posted on: 07/18/2019

Manager Digital Marketing II
Description: Manager Digital Marketing II GENERAL SUMMARY: As a member of the Walden University creative services team, the senior marketing project manager will be responsible for managing broad scale or complex (more...)
Company: Laureate Education
Location: Columbia
Posted on: 07/18/2019

District Sales Manager
Description: Responsibilities br br At Office Depot, the District Manager is responsible for the overall presentation, financial results, execution of company programs and direction of 15-20 store locations, in (more...)
Company: Office Depot OfficeMax
Location: Columbia
Posted on: 07/18/2019

Restaurant Manager - Baltimore Marriott Waterfront (19000ZYV)
Description: Heres To Your Journey with Marriott Hotels Resorts Suites Marriott International portfolio of brands includes both JW Marriott and Marriott Hotels. Marriott Hotels, Marriott Internationals flagship brand (more...)
Company: Marriott International, Inc.
Location: Columbia
Posted on: 07/18/2019

Log In or Create An Account