Regulatory Affairs Lead - Mölndal, Sverige - HR On Demand

Beskrivning

We would like to welcome you to a warm yet highly skilled and experienced team of drug development professionals focused on oligonucleotide therapeutics.

We offer a vibrant collaborative international environment , where science and data are the main driving forces behind our ambition to develop game-changing medicines to our patients. We also offer you the opportunity to grow with our expanding global organization, towards being one of the leading players in the area of oligonucleotide therapeutics .

About us

(Ribocure) is an international R&D Centre based at GoCo in Gothenburg, and is a subsidiary of (Ribo).

Ribo was established in 2007 in China and is a company with a vertically integrated cutting-edge RNAi technology including, patent GalNAc liver-targeting technology –

Ribo-GalSTAR TM , oligonucleotide design, screen, preclinical proof of concept and clinical testing as well as large scale CMC capacity.

Ribocure was established in Jan 2022 in Gothenburg and represents Ribo ́s commitment to globalize its technology and life-saving therapies. Ribocure has a Ph2 clinical trial unit integrated in the core business at our HQ located in our in Gothenburg Sweden and are dedicated to run innovative clinical trials with the focus on rare disease indications to address unmet medical need. (

The role

To further strengthen our global R&D capacity, we are now recruiting a Regulatory Affairs Lead . You will be responsible for providing operational and strategic regulatory leadership to the preclinical and clinical development. With your up-to-date regulatory knowledge, you will contribute to identify future regulatory requirements and proactively drive regulatory interactions to pave the way for innovative clinical development strategies.

What you'll do

• Provide global regulatory strategy guidance to our pipeline based on up-to-date regulatory knowledge and ensure that they comply with relevant laws and regulations.
• Responsible for preparation and submission of regulatory agency applications, reports, and correspondence.
• Prepare and lead interactions with Health Authorities.
• Represent Regulatory Affairs in cross-functional project teams, to deliver high quality global regulatory strategy documents for assigned products.
• Communicate regulatory information to multiple departments.
• Develop and maintain standard operating procedures and local working practices.
• Lead authoring of regulatory documents.

Essential for the role

• Strategic thinking and influencing toward innovative clinical development approaches through proactive and innovative regulatory strategies.
• High competencies in oral and written communication skills and have excellent regulatory knowledge including novel regulatory tools and technologies.
• Academic degree in a science related field.
• Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and/or late development and FDA and EMA submission.
• Experience in preparing and/or leading health authority interactions.
• Demonstrated ability to work collaboratively in a matrix organization.

Desirables for the Role

• Previous experience in oligonucleotide therapies is not a must but strongly preferred.
• > 5 years of experience from large pharma and/or biotech companies

You will be reporting to the Global Head of Regulatory Affairs and the career level will be set based on your experience and competencies.

If you are interested, please do apply as soon as possible. For further questions as a candidate for the role, please contact recruiting manager Maria Liljevald.

You apply easily by clicking on the Send Application-button no later than April 30th, 2024.

Welcome to Ribocure