Director of Regulatory Affairs : Biologics (Interim / Permanent)
Our Client is a very well established international pharmaceutical company, headquartered in continental Europe. Its extensive and impressive product portfolio (commercialised and in development) encompasses a range of therapeutic areas and includes small molecules and biologics.The company’s ambitious plans for the future call for an increased focus on biologics and include the creation within the UK of a “Biotechnology Centre” which will become a centre of excellence for the development (and manufacture of clinical supplies) of an increasing number of assets, which have been licensed in from a number of global partners.
The intention is that the manufacture of product required for Phases II and III studies, and for subsequent commercialisation, will be outsourced.
Work to establish this Biotechnology Centre has already begun, its location agreed (c. M4 / Oxfordshire) and recruitment of key personnel is now very much a priority, with key people required to be in place end 2015 / Jan. 2016 latest.
One of the most important of these newly-created positions is that of Director of Regulatory Affairs (Biologics) – a senior role that will carry responsibility for all aspects of the Regulatory processes that will be involved as the company works on what will be global, rather than purely regional development programmes.
It is anticipated that the company will, over time, develop an impressive external network of other companies such as contract manufacturers and other suppliers of key skills, knowledge and experience.
The role will therefore include a shared responsibility for the creation and maintenance of effective relationships with these external parties, thereby helping ensure the delivery and protection of the company’s interests.
As the number of products increases for which the Biotechnology Centre will be responsible, this key position will clearly need to be filled by a full-time permanent employee, but in the short-term and until such time as the ideal candidate has been identified, an experienced Interim Manager will be appointed, probably for an initial period of 6-12 months, 2-3 days / week. The ideal scenario would be for the Interim Manager to ultimately transition into a position of employment with the company.
Candidates are likely to be educated to at least degree level, have a thorough knowledge of the biotechnology / pharmaceutical industry in general and of biologics in particular. Specific experience of working with antibodies would be a real asset.
Candidates must be able to point to an impressive track record of helping develop and actually registering products, and given that our Client’s new “Biotechnology Centre” will be working on global, rather than purely European development programmes, experience of UK/EU/FDA and other key markets and their Regulatory Agencies is important.
The role will probably involve a small level of international travel (e.g. to the company’s European HQ.)
This is a genuinely exciting opportunity in an ambitious company. The successful candidate will not be inheriting a well-established role in an existing structure, but will instead be making a significant and highly-visible contribution to the creation of something new and of long-term strategic importance to the company.
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