CMC Devices Associate Director / Manager

Collegeville, Pennsylvania; Research Triangle Park, North Carolina
Closing date
Oct 3, 2022

View more

Other, Other
Job Type
Manager, President/CEO/Director/VP
Organization Type
CMC Devices Manager

Role overview

This role manages CMC regulatory activities relating to development, registration and manufacturing of devices (standalone and in all types of drug-device combinations)

Key Responsibilities:
  • Coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and considering the evolving regulatory requirements.  Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies.
  • Mentors or trains staff. May have direct line management responsibility. Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate. Provides strategic direction, data assessment and conclusions within and across departments. Able to establish organisational networks (internal and external) understanding departmental constraints/pressure within a highly complex organisation  
  • Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation, and efficiency) and externally (external advocacy and shaping the regulatory environment). 
  • May deliver CMC regulatory strategy to support major inspections (eg PAIs) or quality incidents (PIRCs).
  • Has accountability for submission content. Understands, interprets, and advises on regulations, guidelines, procedures, and policies relating to development, registration and manufacturing of biopharmaceutical products, to expedite submission, review and approval of global CMC applications.
  • Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensures information submitted in clinical/marketing applications/lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
  • Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work
  • Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company.
  • Operates with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicates sensitive matters or those with potential for high business impact.
  • May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.

Why you?

Basic Requirements:
  • Experience of drug development and manufacturing and supply processes
  • Practice complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
  • Project management experience
  • Track record of negotiating with regulatory agencies, industry bodies, and personnel in a variety of settings

Preferred experience:
  • Detailed knowledge of devices (standalone and in all types of drug-device combinations) in development and manufacturing and supply processes and may have a specialized area of expertise
  • Demonstrated ability to handle complex global CMC device issues through continuous change and improvement
  • multi-tasking skills
  • Development experience ideally including previous roles within pharmaceutical and/or vaccines product development
  • Experience in understanding, interpreting, and advising on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of devices (standalone and in all types of drug-device combinations) to expedite submission, review and approval of global CMC applications
  • Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate internal colleagues and formulate company approaches to meet new requirements most effectively
  • Identified as CMC Regulatory expert in a specific subject area.
  • Highly developed interpersonal, presentation and communication skills with established internal and external networks
  • Proven experience in supervising and training junior staff within and across the organisation and can motivate and lead others

Application Details:

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.

R&D At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable.

We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study startsin 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat, and dostarlimab. In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can domost good. If a project doesn't pan out, we take what we've learned and apply it elsewhere.

Technology can help us find patterns in genetic data better and faster. We're using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we're one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development.

Even with the knowledge, tools, and resources within GSK, there's always a benefit to new perspectives. That's why we're increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world's leading consumer genetics and research company. Other partners include: the Altius Institute; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers; and the Open Targets Consortium, the mindset and approach of smaller, more agile startups.

Find out more: Our approach to R&D.

Why GSK?

At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to, strengthen our leadership and reshape our organisation. Now, we're getting ready to deliver the most significant change to our company in over 20 years. We're on track to separate and create two ambitious new companies in 2022: A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health.

With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We'll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years.

All of this depends on our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.


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