Regulatory Affairs Manager (Drug Device Combination Products) – Vectura Limited – Newton

Vectura Limited

Not all Regulatory Affairs roles are equal.

Is this the role you are looking for If so read on for more details, and make sure to apply today.

There is no shortage of jobs available right now, however, not all of them have the same potential as this one.

This is an opportunity to support both the development and lifecycle management of drug-device combination products, in an organisation that has a diverse range of products, new investment, and plans for future growth and diversification, bringing inhaled medicines to market.

You will join an established and knowledgeable team, in a role where you can really grow your professional career and experience in the drug-device combination inhaled products space.

About the role Depending on experience, you will lead and/or support regulatory activities for Drug-Device Combination products and Medical Devices development and global regulatory activities from initial product concept throughout the product life cycle e.g.

clinical submissions, technical files, marketing applications, response to questions, post-approval submissions and Agency Briefing Documents.

Working as an SME, across multi-functional project teams and with external partners, you will be involved in the preparation, review and compilation of regulatory submissions and associated technical documents.

You will ensure we successfully collaborate to deliver the CMC and device components for regulatory submissions.

Your expertise will help navigate through respective Drug-Device Combination and Medical Device regulatory requirements to ensure the success of ongoing and new development programmes .

Key responsibilities include, but arent limited to: Contribute to the regulatory strategy and global approval of drug-device combination products with particular focus on the requirements in the US, EU, and Japan .

Create final regulatory documentation for Drug Device Combination products Communicate with external partners including clients, regulatory authorities and notified bodies Provide support to key product development activities including inputting to risk management documentation, maintenance and archiving of DHF and Technical Files, and creation of IFU and labels Work with pharmaceutical development, device development, manufacturing, QA and external partners to deliver the device and CMC components of DDC submissions Provide support to the maintenance and archiving of device registrations including a regular review of existing technical documentation in compliance with the relevant standards and legal requirements Identify and analyse the impact of new or changed standards or legal requirements Contribute to the regulatory strategy for clinical trial and commercial activities to include language requirements, local legislation and registrations Using electronic Documentation Management Systems to build submission structures, and to report and track regulatory commitments About you You will have a background in drug-device combination products, either from a pharmaceutical or medical device background, with a good understanding of drug and device development in the EU and US markets, preferably with inhaled products.

In addition, you will have a good working knowledge and ability to interpret regulations and guidelines governing both medicinal product and medical devices.

Aside from the technical requirements of the role, you will be able to form collaborative partnerships with various teams and stakeholders, to influence successful outcomes.

You will have excellent organisation skills, with a keen eye for detail, while demonstrating the ability to solve problems, be able to think strategically, with a good communication skill set.

For the right candidate, you will gain the opportunity to work across a range of different CDMO, co-development and in-house development programmes.

You will be supported and given the opportunity to build on your professional area of expertise to help bring to market inhaled therapies for the treatment of respiratory disease Apply Were at a really exciting point in our journey and we would love for you to be part of it.

If youre interested in a genuine opportunity to grow and develop your professional profile then we would love to hear from you.

Apply today for more information.

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