Manager - Regulatory Affairs - 12 months contract
Chippenham, United Kingdom | Full-Time
Contract Type: Fixed Term Contract
Closing date:
Reference: VN1850
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This is an opportunity to support the development 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 on a 12-month FTC for maternity cover.
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 the global CMC and device related regulatory activities associated with the development of inhaled Drug-Device Combination products from initial product concept throughout the product lifecycle.
You will ensure you 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.
Job Summary:
• Lead or support global regulatory activities for Drug-Device Combination product development from initial product concept throughout the product life cycle by preparing CMC documents for submission to health authorities e.g. clinical trial submissions, response to questions and agency briefing documents. In addition you will prepare and maintain device technical files and support device development activities.
• Work as an SME, across multi-functional project teams and with external partners, involved in the preparation, review and compilation of regulatory submissions and associated technical documents.
• Ensure we successfully collaborate to deliver the CMC and device components for regulatory submissions.
• Provide regulatory guidance on the development of drug device combination products including CMC and device development activities using knowledge of both medicinal products and medical devices requirements (including US, Europe and ROW)
Principal Accountabilities:
• Contribute to the regulatory strategy and global approval of drug device combination products with particular focus on the requirements in US, EU and Japan.
• Create final regulatory documentation for drug device combination products
• Communicate with external partners including clients, regulatory authorities and notified bodies
• Work with pharmaceutical development, device development, manufacturing, QA and external partners to deliver the CMC and device components of the dossier
• Contribute to the regulatory strategy for clinical trial and commercial activities to include language requirements, local legislation and registrations
• Identify and analyse impact of new or changed standards or legal requirements
• Carry out duties in line with regulatory, commercial, quality and business needs and ensure compliance with regulatory legislation and guidelines, and company processes and procedures.
• Manage regulatory intelligence
About you:
You will have a strong background in CMC and 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 US and EU 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 inhaled therapies to market.
Apply:
We’re at a really exciting point in our journey and we would love for you to be part of it.
If you’re 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.
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 the global CMC and device related regulatory activities associated with the development of inhaled Drug-Device Combination products from initial product concept throughout the product lifecycle.
You will ensure you 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.
Job Summary:
• Lead or support global regulatory activities for Drug-Device Combination product development from initial product concept throughout the product life cycle by preparing CMC documents for submission to health authorities e.g. clinical trial submissions, response to questions and agency briefing documents. In addition you will prepare and maintain device technical files and support device development activities.
• Work as an SME, across multi-functional project teams and with external partners, involved in the preparation, review and compilation of regulatory submissions and associated technical documents.
• Ensure we successfully collaborate to deliver the CMC and device components for regulatory submissions.
• Provide regulatory guidance on the development of drug device combination products including CMC and device development activities using knowledge of both medicinal products and medical devices requirements (including US, Europe and ROW)
Principal Accountabilities:
• Contribute to the regulatory strategy and global approval of drug device combination products with particular focus on the requirements in US, EU and Japan.
• Create final regulatory documentation for drug device combination products
• Communicate with external partners including clients, regulatory authorities and notified bodies
• Work with pharmaceutical development, device development, manufacturing, QA and external partners to deliver the CMC and device components of the dossier
• Contribute to the regulatory strategy for clinical trial and commercial activities to include language requirements, local legislation and registrations
• Identify and analyse impact of new or changed standards or legal requirements
• Carry out duties in line with regulatory, commercial, quality and business needs and ensure compliance with regulatory legislation and guidelines, and company processes and procedures.
• Manage regulatory intelligence
About you:
You will have a strong background in CMC and 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 US and EU 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 inhaled therapies to market.
Apply:
We’re at a really exciting point in our journey and we would love for you to be part of it.
If you’re 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.
Chippenham, United Kingdom
1-6 Prospect West
Bumpers Way
Chippenham
SN14 6FH