Regulatory Affairs Manager in Farnborough, ENG - Syneos Health
- Employer
- Syneos Health
- Location
- Farnborough, United Kingdom
- Salary
- Competitive
- Start date
- 22 Feb 2021
- Closing date
- 24 Mar 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Overview
Do you want to work in an environment and culture where you can thrive, develop and advance?
A career with Kinapse means your everyday work improves patients' lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognize our people by providing valuable benefits and a quality of life balance.
Responsibilities
- Part of the Project management team overseeing successful initiation, execution and completion of Regulatory programs for Kinapse' Global client.
- Responsible for managing project deliverables in line with the project plan.
- Oversight of initiation, execution and completion of projects for Kinapse' clients and ensuring delivery is within time and budget; if not, take corrective action.
- Perform content technical review of work by other team members on an ongoing basis.
- Act as subject matter expert and help team members with day-to-day trouble shooting activities.
- Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.
- Keep a vigilant eye on changing processes in industry and suggests areas for improvement in internal processes along with possible solutions.
- Communicate effectively with internal clients to identify needs and evaluate alternative business solutions.
Job Requirements
- Relevant experience in Regulatory affairs and labelling, with exposure to regulatory filings as a part of a pharmaceutical company or CRO.
- Significant knowledge on regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred.
- Experienced people manager.
- Significant knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
- Ability to motivate team members, provide coaching and support development, troubleshooting, tracking deadlines and acting as a primary or second degree reviewer.
- Excellent written communication skills.
- Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel.
We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion
Company
Learn more about this company
Visit this company’s hub to learn about their values, culture, and latest jobs.
Visit employer hubLearn more about this company
Visit this company’s hub to learn about their values, culture, and latest jobs.
Visit employer hubGet job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert