GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and the platform for responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.
We are currently recruiting a Principal Submission Specialist in our Regulatory Platforms & Systems (RP&S), based in the US. Regulatory Platforms and Systems have accountability for all GRA's operational activity with staff based across 8 countries (US, UK, BE, IT, IN, PO. MX, EG). Through execution of these activities, Regulatory Platforms and Systems facilitates achievement of GRA strategic objectives including support for clinical development, new product launches and obtaining and maintaining GSK product licenses worldwide. This position will be predominantly responsible for timely delivery of compliant regulatory submission packages to Regulatory Authorities by supporting the end-to-end processes in place for clinical applications and major submissions, providing expert guidance on technical requirements to R&D Project Teams, and planning and directing of submission support tasks in collaboration with staff at Global Regulatory Centers (GRC). The successful candidate will be involved with a diverse range of activities including:
Why You? Basic requirements:
- Responsible for on-time delivery of electronic applications to Regulatory Authorities for submission types ranging from major, original NCE or Biologic applications through to lifecycle submissions required to maintain application's registered status and fulfil regulatory obligations.
- Fulfilling the role of Global Publishing Lead on Regulatory Matrix teams, acting as the owner for electronic submission application, leading publishing efforts, and coordinating publishing tasks and quality checks with colleagues in GRCs.
- Maintaining knowledge of relevant Regulatory Authority rules and guidance associated with different formats of regulatory submissions (e.g. eCTD).
- Building electronic submissions with standard industry software, using validated processes, and adhering to SOPs and Working Instruction documents.
- Guiding Regulatory Matrix Teams on the optimum submission structure and publishing approach for the complex product applications.
- Negotiating agreements with Regulatory Agencies on specific technical aspects of a major submission which best support the needs of the R&D Project.
- Accurately estimating scale and timing of publishing tasks and collaborating with Submissions Production team to plan and resource effectively and ensure timely and compliant delivery.
- Collaborating across Submissions Production to continuously improve the effectiveness and efficiency of submissions delivery.
- Supporting training and development of publishing staff in accordance with GRA and RP&S standards, as well as requirements established by Regulatory Authorities.
- Two or more years experience publishing electronic submissions for a Regulatory Authority in a major region (e.g. FDA, EMA)
- Two or mor years experience working with document management and publishing software and utilities
- Bachelor's Degree in a related field.
- Knowledge of detailed eCTD submission requirements in multiple regions.
- Ability to present and actively communicate electronic submission requirements and processes and champion change, both within Global Regulatory Affairs and with key stakeholder groups in R&D
- Ability to interpret published external guidance and advise on how to handle internal issues, and respond to technical questions from regulators
- Knowledge of relevant regulations and standards relating to the submission of regulatory applications worldwide
- Project management skills and ability to oversee and prioritize multiple activities across one or more sites for multiple customers
- Strong sense of urgency, able to prioritize effectively such that key issues or emerging high priority matters are handled in a timely and effective way.
- Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
- Ability to make decisions based on technical knowledge and experience within a regulated framework
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; 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 diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas 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 culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
When applying for this role, please use the 'cover letter' of the on-line application 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.
Thank you for your interest in this opportunity.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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