GRL Delegate

As Sr Manager, GRA you have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines.

You lead and/or coordinate regulatory activities specific to EMA, MHRA, EU member state/ROW national competent authorities within your assigned portfolio for development of marketing authorization strategies, briefing/MAA/labeling documents.

You provide input into/manage regulatory activities for development programs in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.

You provide input into the content of or lead preparation/authoring of relevant clinical/labelling sections of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements.

You provide input into briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.).

You act as the GRL delegate to Clinical teams and clinical study meetings and drive clinical regulatory strategies at the project team level.

You support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with global regulations and/or regulatory advice received from the agencies.

Your responsibilities:

• You provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.

• You participate to in-depth project/product-related discussions and provide in-depth strategic, scientific and RA input, for clinical/labelling aspects of a given project, within GRA meetings

• You provide in-depth input on clinical/labelling sections/sub-sections of the Global Regulatory Plan (GRP).

• You provide input into and lead preparation/authoring of clinical section/sub-sections for the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL.

• For cross-product sections or stand-alone documents, you work with the function to ensure content is aligned with targeted overall profile of the product.

• You compile/write high quality project/product specific sub-sections (related to clinical/labelling) of regulatory documents to be submitted to Authorities 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 clinical/labelling strategy, and use of appropriate regulatory procedures to secure the optimum submission strategy; contribute or lead preparation of sub-sections related to clinical/labelling.

• You 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, may possibly escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her responsibility.

• Must possibly be aware of changes in global regulatory guidelines and their impact on regulatory strategy for the particular asset(s).

• You develop and motivate collaborators (within RA team) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.

Basic Qualifications:

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

• Bachelor’s degree in General Science or Life Science Degree.Health Science, Regulatory Affairs, Quality, Information Systems, Business Management or other technical discipline.
• Specialist, Global Regulatory Affairs: 2+ years significant experience in regulatory affairs, or appropriate relevant experience.
• Broad knowledge is required and covers scientific as well as regulatory expertise.
• Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred.Deep understanding of R&D and proven ability to manage and deliver either business or technical projects which included major changes to existing ways of working and embedded culture.
• Ability to coordinate and execute regulatory strategy for a given project/product (as development path).
• 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 (as development path)
• Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
• Good influencing skills.
• Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner.
• Work independently and serve as GRL delegate at clinical teams.Experience working with and improving Quality Management Systems.
• 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.
• Able to input into the Company’s regulatory positioning and write /critically review key documents targeting internal or external key audiences.
• In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.

Preferred qualifications:

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

• Master’s degree in Pharmacy, Chemistry, Biology or Medicine Health Science, Regulatory Affairs, Quality, Information Systems, Business Management or other technical discipline.
• Scientific/pharmaceutical industry background in pharmaceutical research. Previous experience in Compliance and/or Quality Assurance.
• Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams (as development path).
• Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy (as development path).
• Culturally aware.
• Detailed knowledge of the drug development and clinical processes.
• Abreast of how technology is being applied to accelerate R&D and new product introductions.
• Knowledge of global, regional and national regulatory requirements and regulations.
• Ability to deliver key process improvement initiatives.
• Ability to work independently and take decisions with minimal supervision.
• High degree of organizational awareness and working towards resolution with complex problems.
• Demonstrated project management skills and management of complex cross-functional activities.
• Demonstrated ability for good verbal, written and presentation skills.
• Demonstrated strength in change management and influencing skills.

• Li-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.

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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