Sr Regulatory Affairs Specialist - Classic & Established Product, Open to flexible working
Are you interested in a regulatory affairs role that allows you to strategise and accelerate regulatory submissions across the business?
We are seeking a highly motivated and experienced Regulatory Affairs professional to join our within Classic and Established Products Regulatory Affairs team due to growth in the area of drug-device combination products. This is an excellent opportunity to be the regulatory lead developing the regulatory strategy for the device aspects of exciting projects, mainly injectables, as well as influence and shape this emergent team.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Ensure global approaches to the device regulatory strategy of Drug-Device Combination products and Medical Devices to expedite submissions with particular focus on the requirements in the US, EU, Japan and China.
- Lead and/or support Drug-Device Combination products and Medical Devices global filing activities from a regulatory standpoint during the product life cycle e.g. clinical submissions, technical files, marketing applications, response to questions, post-approval submissions and Agency Briefing Documents.
- Lead and/or support preparation and determination of key messages for product and/or portfolio specific regulatory documents and senior management.
- Lead and/or support EU MDR activities for Drug-Device Combination products and Medical Devices with input to the Clinical Evaluation and Post-Marketing Surveillance documents.
- Understand and interpret global regulations/ guidelines relating to Drug-Device Combination products and Medical Devices, as well as contribute to external advocacy.
- Convey regulatory expectations for the device aspects in a manner that is easily understood by both technical and non-technical teams.
- Act as an advisor and partner with functional units on the implementation and training of Drug-Device Combination and Medical Device regulatory requirements.
- Provide device-related advice on data management systems
- Cultivate meaningful and credible partnerships with all the functions of Global Regulatory Affairs, Safety, Medical, , subject matter experts, Notified Bodies and Regulatory Agencies
This role can be based at our GSK House (London, UK) or Upper Providence (Pennsylvania, USA)
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Lifescience/ Pharmaceutical-relatedscience (Chemistry, Pharmacy, Biochemistry, Biology, Device Engineering).
- Minimum of 5 years of experience in CMC Regulatory Affairs with Drug-Device Combinations and Medical Devices in US, EU, Japan and China
- Knowledge of clinical trial and marketing applications in all 4 key markets and sound knowledge globally in human factors testing (ISO/IEC 62366), device risk analysis (ISO 14971), device complaint handling, and other global regulatory requirements for Drug-Device Combination products and Medical Devices.
- Strong knowledge of Drug-Device Combination products and Medical Devices regulations (21 CFR Parts 3, 4, GCP, GLP, 210/211, 600, 700, 807, 809, 803, 812, 814, 312, 314, 1271, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR), MEDDEV, ISO 13485, technical standards, JPAL Ordinance 169, ISO 14155, eCTD Module 3).
- Knowledge of the following regulations would also be advantageous; MDSAP, CMDR SOR/98-282, TGA SR. 236.2002, ANVISA RDC No. 16, MFDS No. 219
- Proven experience and recent demonstrated success of regulatory submission and approval activities including track record of organising and executing successful milestone meetings and proven track record of successful relationships with one or more Health Authorities and Notified Bodies
- Experience in the EU CE Marking process that can be extended to forthcoming UK requirements for UKCA marking.
If you have the following characteristics, it would be a plus:
- Experience and knowledge of biopharmaceuticals, injectables and Drug-Device Combinations would be highly advantageous, as the role involves a significant degree of collaboration with staff operating in these areas.
- RAC, RD, Master's degree or doctorate
- Specialized in Global Drug-Device Combinations and Medical Devices Regulatory Affairs
- Practically-applied demonstration of intellect and an ability to interface effectively and manage relationships at all levels with internal and external stakeholders e.g. technical staff, senior management, Regulatory Agencies, Notified Bodies, Trade Associations.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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