Senior Regulatory Affairs Associate - Generalist
- Employer
- Parexel
- Location
- Ireland
- Salary
- Competitive
- Start date
- 18 Sep 2022
- Closing date
- 17 Oct 2022
View more
- Discipline
- Clinical Research
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
This role can be either office based in Uxbridge or Dublin or you can be fully home based anywhere in the UK or Ireland respectively. The offices are open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world.
As a Senior Regulatory Affairs Associate - Generalistyou will have good technical Regulatory Affairs skills and may be developing specialist knowledge of a particular subject and/or market. In this role, you will ensure the timely completion of work within a project scope and to the quality expectations of the client. You will have a good understanding the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides.
In this role you will carry out:
- Preparation & submissions of regulatory files
- Communicate with Regulatory Operations on the planning of marketing applications and post-approval supplements and variations
- Coordinate the review and approval of submission-ready documents
- Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
Key Accountabilities:
Project Execution
- Works effectively within a team environment
- Works within broad project guidelines as directed by the Project Lead orTechnical SME
- With the guidance of the project Technical SME, demonstrates the ability toprioritize work to achieve specified project outcomes
Consulting Activities and Relationship Management
- Follows and implements the organization’s consulting models andmethodologies under the guidance of the project lead and/or Technical SME
- Delivers a limited range of consulting services within personal area ofexpertise under the guidance of the Project Lead and/or Technical SME
- Completes assigned activities within project scope and objectives under thedirection of the Project Lead and/or Technical SME
Business Development
- Begin networking within the industry (i.e. maintain contacts and relationshipswith clients once engagements are complete)
- Communicates potential new business lead to PC management and accountmanagers
Parexel related responsibilities
- Meets established metrics as specified in scorecard on an annual basis
-Completes basic job-related responsibilities, including timesheets, expensereports, maintenance of CVs, training compliance, project deliverablearchiving, participation in internal initiatives/projects
- Defines self-development activities with the support of management in orderto keep current within the industry.
* Qualifications :
Education:
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
Skills:
- Moderate project management knowledge
- Strong client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Consulting skills
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Critical thinking and problem-solving skills
- Proficiency in local language and extensive working knowledge of the English language
Knowledge and Experience:
- Basic experience in a CRO industry-related environment or experience with a regulatory agency (such as MHRA) is a plus
- Previous CRO or Pharma experience acting in the capacity of a Regulatory Affairs Associate or Junior Regulatory Affairs Associate would be desirable.
- Client-focused approach to work
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.
Apply today to begin your Parexel journey!
Company
When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.
How to describe Parexel’s culture in one word:
Working With Heart™ - Christina's perspective:
Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
United Kingdom
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