Regulatory Affairs Officer gain biologics experience
- Employer
- Mosaic Regulatory Solutions
- Location
- East Midlands Region
- Salary
- Flexible
- Start date
- 21 Sep 2022
- Closing date
- 21 Oct 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Role- Regulatory Officer - 2 years experience needed. You don't have to have biologics experience
Location - Nottingham - Hybrid ( 2 days in office per week )
Salary - Flexible
Job summary
Responsible for contributing to regulatory activities in relation to its recombinant albumin products and technologies. More specifically, the Regulatory Affairs Officer will contribute to lifecycle management of existing regulatory documentation, input to any new regulatory submissions and maintain regulatory intelligence function as well as oversee other regulatory administrative tasks. Key Tasks and responsibilities • Contribute to the submission and maintenance of regulatory filings. • Contributing to the authoring of product regulatory dossiers in compliance with appropriate standards and guidance for biotech/biological products. • Conducting interactions with regulatory authorities regarding products and technologies, as required. • Maintaining awareness of the wider regulatory landscape, taking responsibility for Regulatory Intelligence within the department and disseminating this information as required • Reviewing change controls to provide regulatory assessment of changes where required and implementing changes with support of other department members • Maintaining and creating databases and work schedules as required within the regulatory department • Providing input and support to other groups including cross-functional teams as required. • Interacting with colleagues from all departments within on regulatory issues
Qualifications and Experience
• University Life Sciences Degree or equivalent level qualification. • A minimum of 2 years regulatory affairs experience with pharmaceutical, preferably biotech/biological, products. • Knowledge of biological and biotechnological (biotech) process and product development, GMP requirements and global registration procedures especially in the EU and US • Experience in co-ordination and compilation of product information for regulatory dossiers including master files, clinical trial applications, product licence applications and medical device registrations. Competencies The candidate must possess the following competencies: • Excellent organisational, planning and prioritisation skills • High attention to detail and strong communication skills • Ability to work in a proactive and autonomous manner • Caring for standards to meet the needs of the business • Information seeking to gather critical information and interpret relevance of such information to the regulatory department • Motivation to learn • Pragmatic
Supervisor responsibilities None
Reporting lines Reports to Head of Regulatory Affairs
#regulatoryaffairs#regulatory#regaffairs#biologics#hybridrole#regulatoryroles#regulatoryaffairsofficer
Company
Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.
Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.
We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.
Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.
Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.
- Website
- http://www.mosaicreg.co.uk/
- Telephone
- 07951 082482
- Location
-
Blackheath
London
SE3
GB
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert