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Job Details

Regulatory Affairs Manager

Location
Baltimore, MD, United States

Posted on
Feb 25, 2022

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Profile

The Company

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Vaccitech plc is a clinical stage biopharmaceutical company that spun out of The University of Oxford in 2016 and develops a range of immunotherapies and vaccines to tackle major diseases. The company has a headquarters near Oxford and also has a team and facilities in Maryland, USA.  We have an exciting new role as part of our continued growth in the Maryland office.

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The Role

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You will have oversight of all key US Regulatory Operations within Vaccitech with the role split between these key areas:

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Strategy

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  • Strategic input into and development of regulatory strategy for Vaccitech “nanoparticle” programmes
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  • Provide regulatory feedback in project teams and to senior management
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  • Participate in contacting competent authorities for respective projects/products and interact with internal departments
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  • Maintain familiarity with company products
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Regulatory filings

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  • Develop content, timelines and contingencies for submissions in collaboration with internal and external contributors
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  • Coordinate and participate in preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, INDs) to  key regulatory agencies such as FDA and EMA for approved and investigational products
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  • Oversight of the approval process when subcontracted to a Contract Service Provider
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  • Experience with key electronic submission tools
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  • Ensure that submissions are of high quality, meet all regulatory requirements and are compliant with corporate goals and directives
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  • Keep up to date with changes in regulatory legislation and guidelines
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Other responsibilities include:

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  • Establish regulatory quality systems and required Standard Operating Procedures to guarantee the relevant oversight of all internal and external communications
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  • Planning, undertaking and overseeing product trials
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  • General regulatory and maintenance tasks
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  • Assisting with regulatory inspections
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  • Works closely with Clinical Operations Department to manage regulatory timelines and agreed objectives
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  • Coordinate and lead regulatory advice meetings such as Pre IND
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Qualifications and experience required for the role:

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  • University degree in science (preferred)
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  • 5 to 10 years' experience in regulatory affairs, including experience with nanoparticle technology
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  • Experience in Regulatory Life Cycle Management and eCTD is an advantage, although not required
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  • A thorough understanding of ICH GCP, Regulatory requirements worldwide (particularly FDA and EMA) plus a knowledge of the EU Clinical Trial Regulation and Directives 2001/20/EC,2005/28/EC and 2003/94/EC
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  • Excellent spoken & written English
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  • Proficiency with standard Windows and Office programs
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  • Experience with electronic document management systems and IT knowledge
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  • Good social skills and ability to work in teams
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  • Good analytical and negotiation skills
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Compensation

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  • Salary commensurate with experience 
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  • Additional benefits include employer-funded health, dental and vision insurance; 401k retirement plan; career development opportunities, and paid time off (PTO).
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rn,datePosted:2022-02-25T16:58:00 00:00,validThrough:2022-03-28T03:59:00 00:00,employmentType:FULL_TIME,hiringOrganization:{name:**MEMBERS ONLY**SIGN UP NOW***.,@id:1825215,url:****Regulatory Affairs,workHours:Full time,educationRequirements:Bachelors Degree,@type:JobPosting,@context:****

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