Regulatory Manager, CMC Vaccines Development Projects

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Be You’ at GSK

At GSK, we’re a company with a purpose to help people do more, feel better and live longer.We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. Theseare at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal.You commit to living our values and expectations and performing against our Innovation, Performance and Trustpriorities. In return, GSK commits to providing the right environment for you to thrive.Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively.

Regulatory Manager, CMC Vaccines Development Projects

Your Responsibilities

• You drive the CMC strategy, coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements.
• You provide regulatory advice and guidance to the Technical Development Team and/or Technical Life-Cycle Team (TLCT), Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel, and provides regulatory support to their partners in R&D, Quality Control, Manufacturing, QA and Supply.
• You ensure adequate interaction and partnership with the Global Regulatory Lead’s team in order to define proper regulatory CMC filing strategy.
• You ensure adequate contribution during interactions with Worldwide regulatory authorities.
• You ensure, in a continuous improvement mindset, regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
• You may engage and lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment).
• You may mentor or train staff.
• You may participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
• You may deliver CMC regulatory strategy to support major inspections (eg PAI’s) or quality incidents (PIRCs).
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Degree in Sciences or Medical Sciences (Chemistry, pharmacy, biological or closely related science advanced degree)
• Successfully managed multiple projects simultaneously.
• Sound knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
• Knowledge of CMC regulatory requirements.
• Demonstrated ability to handle global CMC issues through continuous change and improvement
• Strong communication skills
• Fluent in English
  

Preferred Qualifications

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

• Regulatory Affairs Certification (e.g. RAPS).
• Experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of leadership in a matrix environment.
• Sound knowledge of vaccines/biological products development, manufacturing and supply processes.
• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
• Identified as CMC Regulatory expert in a specific subject area.
• Highly developed interpersonal, presentation and communication skills.
• Proven experience in training staff within an organisation.
  

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients– so we deliver what matters better and faster; accountable for impact– with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

• Li-GSK
  

VxRD*

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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