Principal Submission Specialist

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 Submission Delivery Excellence team based in Canada, Poland or India.

Currently, Global Regulatory Operations have accountabilities 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, Global Regulatory Operations 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 in other regions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Responsible for on-time delivery of electronic applications to Regulatory Authorities for submission types ranging from original NCE or Biologic applications and their associated supplements through to lifecycle submissions required to maintain applications’ registered status and fulfil regulatory obligations.

• Integral member of the Global Regulatory Matrix Teams for high profile R&D projects. Represents overall Publishing of the project and negotiates agreements with stakeholders on specific technical aspects of major submissions and timelines for delivery which best support the needs of the R&D Project.

• Accurately estimates scale and timing of publishing tasks and collaborates with Global Submission Managers, Submission Technical Support, and staff in other regions to plan and resource for delivery against aggressive timelines.

• Ensures that content provided by authors are submission ready and formats to GSK standards as required.

• Maintains knowledge of relevant Regulatory Authority rules and guidance associated with different formats of regulatory submissions in multiple regions (e.g. eCTD).

• Building electronic submissions with standard industry software, using validated processes, and adhering to SOPs and Working Instruction documents.

• Advises and guides Regulatory on submission structure and publishing/handoff approach.

• Manages multiple projects/activities at different stages of development at any one time to ensure timely submission or process/system integrity

Why you?

Qualifications and Experience Required

Educational Background:

• Degree in a biological, healthcare, or scientific discipline OR extensive experience within the drug development environment.

Regulatory Experience:

• Minimum of 5 years of global regulatory experience.

• Demonstrated experience publishing electronic submissions for a Regulatory Authority in a major region (e.g., FDA, EMA).

Technical Skills:

• Proficient in the formatting of PDF documents ensuring GSK requirements and standards are met.

• Knowledge of document management and publishing software and utilities.

• Must have computer knowledge (e.g., MS Office, Adobe Acrobat, SharePoint, etc.) and preferably experience with the use of complex IT tools in a large organization (e.g., Veeva Vault).

• Must have knowledge of detailed eCTD submission requirements in multiple regions.

Regulatory Knowledge:

• In-depth knowledge of relevant regulations and standards relating to the submission of regulatory applications worldwide.

Project Management:

• Strong project management skills with the ability to oversee and prioritize multiple activities across one or more sites for multiple customers.

• 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.

Interpersonal Skills:

• Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.

• 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.

• Ability to function as a team player within a matrixed organization.

Decision-Making:

• Ability to make decisions based on technical knowledge and experience within a regulated framework.

• Ability to interpret published external guidance and advise on how to handle internal issues and respond to technical questions from regulators.

Why GSK?

• Career at one of the leading global healthcare companies

• Contract of employment

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible counterparts

• Sports cards (Multisport)

• Possibilities of development within the role and company’s structure

• Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits everyday

• Free car and bike parking, locker rooms and showers

Inclusion & Diversity at GSK: 

As an employer committed to Diversity and Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at [email protected] to discuss your needs.

#LI-GSK

#LI-HYBRID

#LI-DEI
 

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.

GSK is an Equal Opportunity/Affirmative Action Employer. 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/