Regulatory Affairs Officer
Regulatory Affairs Officer
Albumedix is a recognized market-leading developer of albumin-enabled solutions for advanced therapies and next-generation biopharmaceuticals.
We are seeking a motivated and experienced regulatory professional to join us as Regulatory Affairs Officer to provide valuable contributions to Albumedix’ regulatory activities in relation to our recombinant albumin products and technologies.
This is a newly created role and will appeal to you if you can contribute to the lifecycle management of Albumedix’ existing regulatory documentation, input any new regulatory submissions and maintain regulatory intelligence function, in addition to overseeing other regulatory administrative tasks.
You’ll be exceptionally organised and have comprehensive knowledge of biological and biotechnological processes and product development, GMP requirements and global registration procedures (especially in the EU and US). The role will involve interacting with regulatory authorities and you’ll need to be experienced in the coordination and compilation of product information for regulatory dossiers.
As you’ll be interacting with colleagues at all levels across the business and with external stakeholders, you’ll need strong interpersonal and communication skills. High attention to detail will be a key requirement and you will be comfortable making sense of complex, high quantity and sometimes contradictory information to effectively solve problems.
We value our people and are especially proud of our collaborative and friendly culture, based on our values of being Strong, Flexible and Supportive. We continually strive to provide opportunities for our employees to learn, develop and be rewarded.
The role will be based in our newly renovated and modern offices located on the Albumedix Campus in Nottingham with flexibility for some hybrid working.
• Contribute to the submission and maintenance of Albumedix’ regulatory filings.
• Contributing to the authoring of Albumedix product regulatory dossiers in compliance with appropriate standards and guidance for biotech/biological products.
• Conducting interactions with regulatory authorities regarding Albumedix’ 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
QUALIFICATIONS AND PROFILE
To be successful in your application to this exciting opportunity, we’re looking to identify the following on your profile and past history:
• 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 license applications and medical device registrations.
• 25 days annual leave, plus statutory bank holidays
• Attractive salary reflective of skills and experience, and a performance-based bonus scheme
• Defined contribution pension scheme
• Private healthcare scheme
• Optional exercise classes and other social activities
• Excellent access to public transport and free on-site parking
SUBMIT AN APPLICATION:
Please send a CV and Cover Letter to: email@example.com
• Strictly no calls or emails from recruitment agencies - we don’t accept unsolicited CVs from agencies
• We’re not able to assist individuals with visa sponsorship
ABOUT ALBUMEDIX – Dedicated to Better Health
Albumedix is a science-driven, biotechnology company focused on enabling the development and manufacture of advanced therapies and next-generation biopharmaceuticals through its innovative albumin-based solution platform, including its highest quality Recombinant Human Albumin products, hands-on Compliance and Development Services, as well as proprietary drug delivery technology.
We believe in Empowering Excellence to enable transformative and otherwise unviable therapies reach patients worldwide. We are proud to be recognized as the world leader in recombinant human albumin with products and technologies used in clinical and marketed drugs by pharmaceutical companies worldwide.
Headquartered in Nottingham, England with more than 100 people all committed to improving patient quality of life. We are just as passionate about albumin and albumin-enabled therapies today as we were when we started 30 years ago.