GSK

Global Regulatory Policy & Intelligence (GRPI) Manager, Emerging Markets (EM)

Job posted: Oct 08, 2024
London, Greater London, United Kingdom
  • Salary average
    -
  • Type of employment
    Full-time
  • Remote
    n/a

Company

We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

We prioritise innovation in vaccines and specialty medicines to prevent and treat disease.

Responsibilities

  • Provide interpretation, advice and perspectives on possible impact on GSK of regional legislation, guidelines and policies for assigned topics and countries in scope in support of GSK biopharmaceutical portfolio in partnership with the GRA regional organisation
  • Build, lead and monitor the implementation of an advocacy plan to support faster approval of Innovation in selected countries in scope for the Acceleration in Region (AiR) project by using Facilitated Regulatory Pathways (accelerated pathways and Reliance/collaborative/ work-sharing).
  • Support increased use of Facilitated Regulatory pathways by catch-up assets teams and assets teams within AiR and their integration in the asset Global Regulatory strategy, by building toolkit and appropriate materials on facilitated regulatory pathways for AiR countries.
  • Interact with key regulatory agencies, government and trade associations in GCI & EM on assigned topic areas, including representing GSK in Trade associations meetings
  • Liaise with regional and central GRA teams to discuss and interpret emerging intelligence for the region, participating in specific GRA implementation teams to address major legislative changes as required.

Contract

40 hours per week

Candidate requirements

  • Knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry in the region
  • Understanding of regional external regulatory environment
  • Experience in a regulatory affairs function/role, with knowledge of all phases of the drug development process including Biologicals
  • Experience in regulatory policy and advocacy, or in regulatory regional roles

Skills used at work

  • Business
  • Matrix

Site Name: UK – London – New Oxford Street

Posted Date: Oct 8 2024

Join GSK as Global Regulatory Policy & Intelligence (GRPI) Manager, Emerging Markets (EM) to contribute to the success of regulatory policy, advocacy and intelligence activities in EM within a global team, with a specific focus on accelerating innovation in regions. You will contribute to GRA activities to influence and shape the global regulatory environment.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

  • Provide interpretation, advice and perspectives on possible impact on GSK of regional legislation, guidelines and policies for assigned topics and countries in scope in support of GSK biopharmaceutical portfolio in partnership with the GRA regional organisation
  • Build, lead and monitor the implementation of an advocacy plan to support faster approval of Innovation in selected countries in scope for the Acceleration in Region (AiR) project by using Facilitated Regulatory Pathways (accelerated pathways and Reliance/collaborative/ work-sharing).
  • Support increased use of Facilitated Regulatory pathways by catch-up assets teams and assets teams within AiR and their integration in the asset Global Regulatory strategy, by building toolkit and appropriate materials on facilitated regulatory pathways for AiR countries.
  • Interact with key regulatory agencies, government and trade associations in GCI & EM on assigned topic areas, including representing GSK in Trade associations meetings
  • Liaise with regional and central GRA teams to discuss and interpret emerging intelligence for the region, participating in specific GRA implementation teams to address major legislative changes as required.

Why you?

Basic Qualifications & Skills:

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

  • Bachelor's Degree in Life Science
  • Experience in a regulatory affairs function/role, with knowledge of all phases of the drug development process including Biologicals
  • Experience in regulatory policy and advocacy, or in regulatory regional roles
  • Understanding of regional external regulatory environment
  • Excellent interpersonal skills.
  • Skilled at working and delivering in the matrix

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

  • Degree in Regulatory Affairs
  • Proficient in influencing and negotiation with internal and external stakeholders
  • Translate complex regulations into simple messages that articulate the impact to the business
  • Knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry in the region.

Closing Date for Applications – 22 Oct 2024 (COB)

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.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

Find out more:

Our approach to R&D.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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Job posted: Oct 08, 2024

Expiration date: Oct 23, 2024