Dedicated to Better Health – Albumedix offers a unique opportunity to join an established biotech company and take part in enabling better therapies for patients worldwide through our innovative products and technologies.
We are seeking a dynamic and experienced regulatory professional to join us as Regulatory Affairs Director to lead the regulatory affairs function at Albumedix. In this position, you will be responsible for all regulatory activities in Albumedix including regulatory documentation, regulatory strategy and customer support pertaining to regulatory issues.
Based in offices in Nottingham, UK, with commercial activities globally, this role will involve overseeing the submission and maintenance of regulatory filings. Further to this, you will be developing and implementing Albumedix’ regulatory strategy for both existing and new products, in addition to keeping up with the global regulatory environment for biological/biotechnological pharmaceutical components. In this role, you will manage contact with regulatory authorities regarding Albumedix’ products and technologies as well as supporting users of Albumedix’ offerings worldwide with their product registrations
This is an exciting opportunity working in a fast-paced and agile environment where you will be supporting and engaging with a variety of internal stakeholders such as executive management and colleagues from other functions including Manufacturing, Quality, R&D and Commercial. We pursue a collaborative, ‘outside-in’ work culture based on open communication, fast and effective decision making and a flat hierarchy. The position is full-time, and will entail a certain amount of overseas travel.
QUALIFICATIONS AND PROFILE
- Life Sciences, Chemistry, Pharmaceutical or Biotechnology university degree required, masters or other postgraduate qualification in pharmaceutical regulatory affairs preferred
- A minimum of 7-10 years regulatory affairs experience with pharmaceutical, preferably biotech/biological, products
- Comprehensive knowledge of biological and biotechnological (biotech) process and product development, GMP requirements and global registration procedures especially EU and US
- Extensive experience in co-ordination and compilation of biotech product information for regulatory dossiers including master files, clinical trial applications, product licence applications and medical device registrations
- Excellent awareness of current requirements for biotech component products for use in the manufacture of other pharmaceuticals and medical devices
- Experience in working with state-of-the-art regulatory dossiers in compliance with eCTD structure, format and content with associated use of required software
- Broad experience of direct liaison with regulatory authorities including agency personnel from FDA, EMA, European Commission, MHRA and Health Canada
- Ability to work independently with good attention to detail as well as an effective team player
- Flexible towards and able to change priorities as well as comfortable multitasking
- Excellent written and verbal communication skills
- Attentive to detail and analytical in work while remaining focused on the primary objective
- Effective and demonstrated leadership skills
- Positive attitude and a commitment to actively developing own and colleagues’ skill base
- Market 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
- City centre location with on-site car and bicycle parking and excellent access to public transport
Albumedix is a science-driven, biotechnology company focused on improving patient outcomes through its albumin-based products and technologies for the development of superior biopharmaceuticals. Dedicated to Better Health, we partner with excellence to improve therapies for people with serious diseases. 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 80 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. www.albumedix.com
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- Employer: Albumedix
- Updated: 7th January 2019
- Expires: 4th February 2019