Senior Regulatory Affairs Consultant
- Employer
- Parexel
- Location
- France
- Salary
- Competitive
- Start date
- 28 May 2023
- Closing date
- 27 Jun 2023
View more
- Discipline
- Clinical Research
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Key Deliverables in the role:
- Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead.
- Regulatory submission of Clinical Trial in Belgium and France according to EU-CT directive but also via EU-CTR process (experience in this field would be appreciated).
- Regulatory submission of Compassionate Use Program and Observational studies in Belgium and France according to local legislation.
- You will be responsible for the labelling of the health products used in those studies, with creation of the master label, review of the regulatory requirements for Belgium and France and translation / review of the translation for all French speaking countries.
- Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
You will need:
- Educated to at least Bachelor of Science level or Bachelor of Science
- Relevant clinical research experience in regulatory affairs and management of international clinical trials
- Fluent in written and spoken English as well as local language
- Extensive prioritization skills; must be able to resolve conflicting priorities to meet tight deadlines while maintaining quality and attention to details
- Ability to work with a multinational team, focusing on multiple issues under tight timelines
- Creative problem-solving skills, which supports client-focused approach to work
- Experience in clinical study start-up
Benefits of working at Parexel
Our success depends on the knowledge and capabilities of our teams here at Parexel. We are committed to developing our employees in a continuous learning environment - one where we challenge you with engaging work and where every experience adds to your career development.
We can reward you with work/life balance and a comprehensive and competitive total reward package that comprises, competitive base salary, combined with recognition programs, employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career.
We encourage you to apply now!
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
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert