Manager, Devices (CMC Regulatory), 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 expanding Devices group within Global CMC Regulatory Affairs 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.
Key Responsibilities include, but are not limited to:
- 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 development and global filing activities from a regulatory standpoint from initial product concept through 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 creation and maintenance of Technical Files, Responses to Questions and the EU declaration of conformity.
- 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.
- Influence and shape the CMC Regulatory Devices group by contributing to the development and implementation of GSK's global processes for Drug-Device Combinations and Medical Devices.
- 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, CMC development, the global manufacturing organisation, subject matter experts, Notified Bodies and Regulatory Agencies.
Closing Date for Applications: Tuesday 13th April 2021
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
This role can be based at our Ware R&D site (Hertfordshire, UK)or at Upper Providence (Pennsylvania, USA).
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Life science/Pharmaceutical-related science (Chemistry, Pharmacy, Biochemistry, Biology, Device Engineering).
- Experienced 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 4key 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.
- 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
- 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 EUCE 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.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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