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PAREXEL International Corporation Job Title
Regulatory Affairs Consultant - Generalist

PAREXEL International Corporation

Job Description
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Regulatory Affairs Consultant - Generalist
United States of America - Remote - Northeast
Date posted
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Success Profile
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As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
Full Time
Travel: Yes
Glassdoor Reviews and Company Rating
Success Profile
Check out the top traits we're looking for and see if you have the right mix.
"When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."
Chris – Associate Director, Regulatory & Access
"In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"
Riley – Regulatory Affairs Consultant
Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Work with industry leaders and subject matter experts.
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Opportunities to work on multiple accounts – never boring!
Strong management with depth of experience working for global health authorities.
Tremendous home-based opportunity for a Regulatory Affairs Generalist to join Parexel's highly recognized Regulatory Consulting Team!
We are seeking an experienced Regulatory Generalist to join our team as a Senior Regulatory Affairs Associate to work closely with one large, dedicated client and provide operational support in the IND/NDA maintenance stage. The Sr. Associate will also provide appropriate regulatory guidance to Project Teams for the development of regulatory submissions and be responsible for the overall quality of submissions; manages, reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards.
Additionally, a Sr. Associate must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as profound knowledge within a business context of what services Parexel Regulatory Consulting provides. 
Provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.
Provides guidance to project team members on technical/process issues
Ensures the timely performance of work within a project scope to the quality expectations of PC and the client
Anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.
Project Execution
Works within a team environment or individually based on the project needs
Works within broad project guidelines and facilitates issue and conflict resolutions
Prioritizes own workload and may prioritize the work load of the project team in order to achieve the project scope
Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
Leverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisions
Produces quality work that meets the expectations of Parexel and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and Parexel are met
Manages small projects and may manage larger project engagements
Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support
Provides guidance to project team members, and acts as a mentor to junior staff
Consulting Activities and Relationship Management
Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
Facilitates client decision making by framing issues, presenting options and providing objective business advice
Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities
Acts as a trusted advisor to clients and/or project team on technical and/or process issues
Develops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
Interacts professionally at multiple levels including senior management within a client organization
Successfully penetrates executive management levels or other business units within a client organization
Facilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
Identifies opportunities for follow-on business or changes in project scope with Parexel Regulatory management and account management
To ensure success, we are looking for individuals that have:
3 years’ experience in an industry-related environment; Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries. Previous CRO experience is a plus
3 years of experience in General Regulatory Affairs with previous experience in the preparation and leadership of teams for IND and NDA submissions to include reviewing and/or writing sections of IND and/or NDA applications from a clinical, nonclinical, or CMC regulatory perspective for a Sr Associate role 
Previous experience preparing regulatory materials for meetings
Candidates with previous experience defining RA strategies are highly preferred for Consultant level roles
Previous small molecule experience is highly preferred
Knowledge of FDA processes and regulations
Familiarity/experience with FDA interactions (verbal or written) is required
Experience with project lifecycle and management
Medical device experience is a plus
Education - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred
Language Skills - At least fluent vocal and written English
Travel Required - up to 30% Domestic or International may be required in the future dependent upon clients' needs
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Apply Now
FAQ: Hiring during COVID-19
Learn how we recruit the best minds in these unprecedented times.
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Our hiring process
Find out what to expect when applying to Parexel
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Flexible Work Arrangement
In-office, home-based or a mix? What’s your preference? We value the work-life balance of our employees, and as such Parexel is offering maximum flexibility to our employees wherever possible.
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Meet Stephanie: Associate Director, Regulatory & Access
Stephanie shares her story about her development within Parexel and what it's like to work here.
Learn More

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