Regulatory Affairs Manager ** Central London ** Full lifecycle role from CTA’s to CeP’s
Location: Central London
Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.
This role will suit a regulatory affairs professional with around 4-6 years’ experience who wants to be in a varied and broad-based role where there are lots of opportunities for development.
This is a great opportunity to be part of something special… and this is the perfect role for a regulatory professional with experience of development projects and/or supporting MAA’s and lifecycle activities to take a central role with increasing levels of strategic input for EU development projects and CeP submissions for indications in both mid and late stage development (with great training available).
Within this dynamic global regulatory affairs environment you will be working in a mixed role covering drug development, product registrations & line extensions of products/projects where you will also receive great training and the opportunity to cross into new therapy areas and cover all stages of development.
In the short term you will operate as the strategic regulatory liaison for your projects, supporting post-marketing licensing requirements and ensuring effective liaison across the organisation to optimise regulatory strategies and leading responses to review queries from Health Authorities. You will also manage the CTA submission process and ensure successful approval of CTA applications, defining CTA strategies, including appropriate oversight and management of CRO vendors.
In the longer term you will continue to grow and move into the development space supporting indications in Phases II and III to MAA via CeP across a strong portfolio where you will supported in your growth, development and training.
The salary, benefits and relocation package for this organisation are excellent and you will also receive real training and career progression from an organisation that is well known for giving its regulatory team strong career development. They will offer you an exciting job and challenges in an international environment, clear career development opportunities, a good work/life balance and an attractive salary package with extra-legal advantages.
To be successful here you will need to be a team player, have great communication and interpersonal skills and be resilient. If you want to a have a role where you can make a difference and have an impact, then please apply.
For this position you will need:
- Excellent EU post approval experience including variations and life cycle management through European procedures (CP, DCP, MRP) and ideally some experience on working on CTA’s.
- The ability to work well within a matrix environment, build team relationships and interface in a global team environment at all levels of management.
- Proven ability to plan, effectively coordinate and lead activities simultaneously on multiple projects, many with tight time deadlines
- Some experience in EU regulatory submissions, with specific experience of clinical and non-clinical submissions to Health Authorities.
To apply, please send a full CV to CV@AdvTalent.com, or alternatively, contact Theo Moore on +44 (0)207 801 3384. We are assigned these roles by our client and will provide you with support throughout the hiring process.
About Advanced Search & Our Network
Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.
Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.
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+44 (0)207 801 3380
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