Regulatory Affairs Generalist - EU & US Remote
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
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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)
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