Regulatory Affairs Generalist - EU & US

Regulatory Affairs Generalist - EU & US Remote

Parexel
Full Time Remote 10.56 - 12.04 GBP Today
Job description

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.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.


Tremendous 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 Senior 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 EMA to assure compliance with regulatory standards.

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

  • 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

  • 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

  • Facilitates client decision making by framing issues, presenting options and providing objective business advice

  • Acts as a trusted advisor to clients and/or project team on technical and/or process issues

  • Facilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems

  • Identifies opportunities for follow-on business or changes in project scope with Parexel Regulatory management and account management


Skills and Experience required for the role:

  • Education - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred

  • 3+ years’ experience in an industry-related environment; Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries

  • 3+ years of experience in General Regulatory Affairs with previous experience in the preparation of IND, CTA, MAA, NDA submissions to include reviewing and/or writing sections of applications from a clinical, nonclinical, or CMC regulatory perspective

  • Submission and maintenance of official local drug information, including Patient Information Leaflets, USPI, SmPCs, packaging texts, RMPs and their Educational Material.

  • Review, preparation and filing of post- approval license variations/ amendments

  • Assists senior RA team members with new NDA/ MA submissions e.g. Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness

  • Knowledge of FDA and EMA processes and regulations

  • Familiarity/experience with FDA and EMA interactions (verbal or written)


#LI-REMOTE

Regulatory Affairs Generalist - EU & US
Parexel

www.parexel.com
Newton, United States
Jamie Macdonald
$2 to $5 billion (USD)
10000+ Employees
Company - Private
Biotech & Pharmaceuticals
1982
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