Senior Manager, Global Regulatory Affairs – GSK – Waver

Site Name: Belgium-Wavre
Posted Date: Sep 28 2021

As a Senior Manager, Global Regulatory Affairs, you will have global responsibility of given activities for a Project/Product within GSK Vaccines.

The purpose of the job is to provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.

The role includes the following responsibilities:

• You provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
• You interact with internal stakeholders and project, platform, and functional teams to provide support for technical/CMC and procedural aspects of a given project.
• You participate to project/product-related discussions as a subject-matter expert
• You provide in-depth strategic, scientific and RA input, for technical/CMC and procedural aspects of given project.
• You provide in-depth input into the asset specific regulatory strategy on a global scale for technical/CMC and procedural aspects.
• You coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• You compile/write/review high quality project/product specific regulatory documents to be submitted to Authorities for technical/CMC sections and ensure that those documents meet regulatory requirements.
• You provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/CMC and appropriate regulatory procedures to secure the optimum submission strategy; contribute for technical/CMC and/or procedural aspects.
• You facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for technical/CMC and/or procedural aspects
• Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s)
• In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL.

Why you?

Basic Qualifications:

• Advanced Scientific Degree
• Experience in regulatory affairs from a technical / CMC aspects, preferably within biologics and/or vaccines
• Ability to coordinate and execute regulatory strategy for a given project/product.
• Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
• Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximise opportunities, with proven ability to develop collaborative relationships and have high impact and influence
• Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
• Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
• Good influencing skills.
• Culturally aware.
• Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
• Ability to resolve problems through resourceful use of information and contacts.
• Enterprise thinking – needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.
• Quality mindset
• Fluent in English, with excellent writing skills.

Preferred Qualifications:

• Ph.D. or Pharm D., Area of Specialisation: Pharmacy, Chemistry, Biology or Medicine

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 in a culture of Innovation, Performance and Trust.

GSK Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation’s three priority diseases – HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.

When it comes to developing the vaccines of the future, we’re looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.

We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

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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