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Head of Regulatory Affairs - Biologics / ATMP

Nottingham, Nottinghamshire NG2 3ED   •  £85K per annum plus a generous bonus scheme and benefits  •  Permanent, Full time

Are you an experienced regulatory affairs professional with a background in biologics or advanced therapy medicinal products (ATMPs)?

Do you want to work for a growing and successful business where you will feel welcomed and supported by a friendly, talented and motivated team of people? A culture where we care about each other, and a position where we will trust and empower you to develop and shape the role?

If this sounds like a place where you will thrive, this is a great time to join Albumedix.

The role:

Albumedix, now part of Sartorius, is a recognized market-leading developer of albumin-enabled solutions for advanced therapies and next-generation biopharmaceuticals.

We are seeking a pragmatic and experienced regulatory professional to join us as Head of Regulatory Affairs to take responsibility for regulatory documentation, regulatory strategy and customer support pertaining to regulatory issues at Albumedix.

This role will appeal to you if you can take the lead on Albumedix’ regulatory activities in relation to its recombinant albumin products and technologies. You’ll be exceptionally organized and have comprehensive knowledge of biological and biotechnological processes and product development, GMP requirements and global registration procedures (especially in the EU and US).

We are keen to speak with candidates who can demonstrate extensive experience in co-ordination and compilation of biotech product information for regulatory dossiers and those with excellent awareness of current requirements for biotech component products for use in the manufacture of other pharmaceuticals and medical devices.

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.

Reporting directly to our Vice President of Commercial Operations, you’ll have autonomy within your role and be responsible for our Regulatory Affairs Manager.

You’ll work as part of a small team based in our newly renovated and modern offices located on the Albumedix Campus in Nottingham, with flexibility for some hybrid working. The position is full-time and will entail a certain amount of overseas travel.

  • Oversee the submission and maintenance of Albumedix’ regulatory filings.
  • Apply knowledge of regulatory requirements to the review of scientific/process documentation and supporting country-specific documents intended for submission to regulatory authorities.
  • Develop and implement Albumedix’ regulatory strategy for new products and life cycle management of registered products.
  • Assess the impact of new regulations and guidance documents for making process improvements within the company.
  • Respond to questions from regulatory reviewers from global agencies on Albumedix’ products and technologies.
  • Provide regulatory support for Albumedix’ customers in a variety of therapeutic applications, including representing the company at customers’ meetings with the regulatory agencies.
  • Develop and review staff performance, such as mentoring and recruiting staff.
  • Manage department budget

About you:

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, Chemistry, Pharmaceutical or Biotechnology university degree.
  • A minimum of 7-10 years of regulatory affairs experience with pharmaceuticals, preferably biotech/biological products, or advanced therapy medicinal products (ATMPs).
  • Comprehensive knowledge of biological and biotechnological processes and product development, GMP requirements and global registration procedures, especially in the 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, e.g. Extedo, DocuBridge
  • Broad experience in direct liaison with regulatory authorities (face-to-face meetings and online/telephone conferences), including agency personnel from FDA, EMA, European Commission, MHRA and Health Canada
  • Good connections with relevant pharmaceutical trade organisations, e.g. International Pharmaceutical Excipients Council Europe (IPEC Europe), and Parenteral Drug Association (PDA).
  • Demonstrated people management experience would be preferred

What we offer:

  • An annual salary £85K plus a generous bonus scheme
  • 25 days annual leave, plus statutory bank holidays
  • Defined contribution pension
  • Private healthcare
  • Optional exercise classes and other social activities
  • Excellent access to public transport

Who we are:

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.

How to apply:

Please send your CV and covering letter via the 'Apply' link, we aim to respond within two working days.

If you'd like to discuss this role, contact Simeon Ractliffe in confidence on 0115 698 0303 or email: simeonr@n2talent.com

N2 Talent is recruiting for this position on behalf of Albumedix. We handle all enquiries, applications, and personal data in a safe and strictly confidential manner.

Please provide confirmation of your eligibility to work in the UK. We’re unable to consider and assist individuals who require visa sponsorship.


Related skills: Biology, Life Science, Regulatory Affairs, Research

You must have the right to work in the UK. Learn more

  • Employer: Albumedix
  • Contact: Simeon Ractliffe
  • Phone: 0115 698 0303
  • Updated: 24th January 2023
  • Expires: 17th February 2023


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