Regulatory Affairs Officer gain biologics experience

September 23, 2022

Job Description

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