Senior Director, Regulatory CMC – Advanced Therapies/Gene & Cell Therapies. Regulatory CMC Subject Matter Expert and primary point of contact with the Regulatory Authorities.
This is a sensational Senior Regulatory CMC role: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London; superb role and a career-making challenge.
Product Development in Phases I to III, Registrations and Post marketing activity. Advanced Therapies/Gene & Cell Therapies Product experience highly desirable. Rare Disease Products/Orphan Drugs. Europe and Switzerland focus. Line Manage the Team within a Matrix-management environment. High-level Project Leading in addition to Line management of a small team – this role is a combination of Strategy, Development, ‘hands-on’ and people management.
This is a superb Regulatory CMC opportunity with significant commercial possibilities. Experience in Advanced Therapies is ideal, along with General Biologics. High-Level Project Leadership skills are vital, along with a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, throughout the Regulatory pipeline. This individual will be responsible for the Regulatory Strategy of several key products hence this is a very important hire. Geographical remit: Europe, USA and some International – knowledge of USA/FDA would be beneficial.
Reporting to the VP of Regulatory Affairs, this position has several reports in Europe and the UK within Regulatory Affairs. The candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have a good perception of how Regulatory CMC issues can impact on profitability.
There are several existing products in the pipeline hence the candidate’s responsibilities will encompass taking the assigned products successfully through Late Phases through to successful BLA’s/MAA’s.
The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a deep understanding of Core Regulatory Affairs, particularly in Europe. The geographic scope of this role is Pan-European, within the context of Global Regulatory Affairs. The candidate will possess full Regulatory pipeline experience, but with specific strengths in Clinical and Development Regulatory Affairs in Phases I to IV.
Although there is a small team to manage, the company operates more on a matrix-management model hence the candidate must be prepared to be ‘hands-on’ and be heavily involved in the day-to-day management of Projects. The candidate will need to have a substantial background in Development Regulatory, ideally: IMPD's, IB's, Protocols, up-dates/amendments, and End of Trial Notifications – in conjunction with the management of CRO’s. CTD/Dossiers for MAA's (particularly Modules 3 and 2.3); National Submissions/MRP, DCP, and particularly Centralised Procedure; Regulatory Strategy, Tactics, and Implementation; Regulatory Intelligence, Scientific Advice meetings with the EMA. PIP's.
A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA and other national Authorities would be an advantage in terms of company representation.
The successful candidate will possess a substantial Regulatory Affairs background within Biologics or Pharmaceutical of at least 10+ years. The candidate will demonstrate superb management and Project Leading skills along with mentoring of staff and the ability to develop and expand a team when necessary.
This position is based Central London and requires travel as can be expected with a role of this seniority.
A significant salary package is on offer for the right candidate, this will include a superb basic, LTI’s, excellent bonus and numerous other benefits.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 1582 290 636; +44 7447 977 330, or firstname.lastname@example.org, or submit an application by clicking Apply Now.