Senior Manager, Regulatory Affairs

Recruiter
Vectura Limited
Location
Chippenham
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Senior Manager, Regulatory Affairs

If you are an expert in Pharmaceutical regulatory affairs and want to be part of a team that transforms the lives of airways disease patients then Vectura is very keen to hear from you.

We have a fantastic opportunity for a talented regulatory affairs professional to join Vectura at a very exciting time. As Senior Manager, Regulatory Affairs you will play an integral role in supporting key projects at key stages of development, both in Europe and in US.

Your experience and expertise will ensure all matters relating to pharmaceutical industry regulations are managed, in accordance with legislation, at a global level. Utilising your first class communications skills you will build and develop relationships with partners including CMC, US and CRO regulatory team members and external regulatory agencies in Europe and US. Your pragmatic style will ensure that important timescales and project milestones are met whilst maintaining a robust, yet respectful and adaptable, approach to feedback.

Other core responsibilities will include (but not limited to); CTA applications and maintenance of CTA/IND approvals, IND submissions, responses to Regulatory Agency questions, scientific advice requests and providing Regulatory support for MAA/NDA submissions.

To be considered for the post of Senior Manager, Regulatory Affairs you will have proven track record in global regulatory drug development, with an emphasis on experience of Europe and the US. You will be able to demonstrate a broad knowledge of industry regulations and have a high attention to detail for writing regulatory documents. You will also have previous experience in supporting and submitting MAAs in the EU including use of the de-centralised process.

Degree educated you will be a capable, independent worker with excellent collaborative skills when working with the wider project team. You will have the thirst for continual development and be able to demonstrate the ability to work across a matrixed organisation. Experience of the Respiratory medicinal product market is desirable but not essential.

Vectura is a growing business, currently based across six sites and four countries. As an organisation we are both passionate and ambitious in our goal to be a global leader in airways disease product and device development. Our continued investment in innovation, sustained organic growth and strategic partnerships have ensured Vectura is at the cutting edge within our niche market.

In return we offer a competitive base salary, bonus and generous benefits package including pension, life assurance, share options/save schemes, private health and dental care.

If you are keen to find out more then please do get in touch.