GSK

CMC Regulatory Affairs Sr. Specialist - Devices

Employer
GSK
Location
Collegeville, Pennsylvania; Waltham, Massachusetts
Salary
Competitive
Posted
October 27 2020
Ref
269039
Organization Type
Pharma
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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

  • Ensu re global approaches to the device regulatory strategy of D rug- D evice C ombination products and M edical D evices 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 .


  • L ead 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 .


  • U nderstan d and interpret global regulations / guidelines relating to D rug- D evice C ombination products and M edical D evices, as well as contribu te to external advocacy.


  • C onvey regulatory expectations for the device aspects in a manner that is easily understood by both technical and non-technical teams.


  • Influenc e and shap e the CMC Regulatory Devices group by contributing to the development and implementation of GSK's global processes for Drug-Device Combinations and Medical D evice s


  • Act as an advisor and partner with functional units on the implementation and training of Drug-Device Combination and Medical Device regulatory requirements.


  • Provid e device-related advice on data management systems
  • Cultivat e meaningful and credible partnerships with a ll the functions of Global Regulatory Affairs, CMC development , the global manufacturing organisation, subject matter experts, Notified Bodies and R egulatory A gencies


Location:

This role can be based at our Ware R&D site (Hertfordshire, UK) at Upper Providence (Pennsylvania, USA) or at Waltham (Boston, USA).

Why You?

Basic Qualifications:

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).
  • Minimum of 5 years of experience in CMC Regulatory Affairs with Drug-Device Combinations and Medical Devices in US, EU , Japan and China  
  • K nowledge of clinical trial and marketing application s 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.
  • K nowledge 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 Directive s and Regulation (MDR) , MEDDEV , ISO 13485, technical standards, JPAL Ordinance 169, ISO 14155, eCTD Module 3 ] .
  • Knowledge of the following regulations would al so be advantageous ; MDSAP, CMDR SOR/98-282, TGA SR. 236.2002, ANVISA RDC No. 16 , MFDS No. 219


  • E xperience 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 relationship s with one or more Health Authorit ies and Notified Bod ies
  • Experience in the EU CE Marking process that can be extended to forthcoming UK requirements for UK CA marking.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Experience and knowledge of b iopharmaceuticals, i njectables 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, R egulator y Agencies , Notified Bodies, T rade A ssociations .


Why GSK?

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.

*LI-GSK

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