Regulatory Specialist, Submission Delivery Excellence

Regulatory Specialist, Submission Delivery Excellence

Regulatory Specialist, Submission Delivery Excellence works closely with global submission teams, Local Operating Company regulatory contact to deliver end-to-end submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.

This role offers an excellent opportunity to develop your expertise in Regulatory Affairs while collaborating with cross-functional teams and gaining exposure to global submission processes.

These responsibilities include some of the following

• Responsible to deliver marketing applications and lifecycle maintenance submissions—including activities such as product renewals and site registrations/renewals/variation submissions—within agreed timelines, in compliance with Regulatory Authority regulations and guidelines, GSK SOPs, and working practices, and in collaboration with relevant submission teams as needed.
• Coordinate MSR for various types of submission, independently and confidently executing agreed dossier strategy. Assist in scenario planning when multiple regulatory strategies are considered.
• Executes the end-to-end coordination, preparation, and delivery of regulatory registration samples, in partnership with manufacturing sites, third party service providers, Central representatives and LOC/PT
• Identify and escalate risks associated with submission delivery that have business impact.
• Understand and apply regulations, guidelines, procedures, and policies relating to the registration and manufacturing of pharmaceutical products to expedite submission delivery.  delivery.
• Participating in process improvement initiatives, as required
• Participate as needed in submission teams to support product regulatory authority submissions or maintenance activities for approved products, including product renewals, site registrations/renewals/variations, and periodic benefit risk evaluation report (PBRER) submissions.
• Mentoring/training of other team members as required.

Why You?

Qualifications:

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

• Degree in a biological, healthcare or scientific discipline or Extensive experience in the Regulatory Affairs area.
• Understanding of the pharmaceutical industry , R&D processes and objectives.
• Ability to interpret regulations
• Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
• Ability to think flexibly in order to meet shifting priorities and timelines.
• Good written and verbal communication skills and ability to present information in a clear and concise manner.
• Good organizational skills, attention to detail and commitment to deliver high quality output in a timely manner.
• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
• Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc.

Why Gsk?

What We Offer:

• Career at one of the leading global healthcare companies
• Hybrid work (2/3 days per week from the office)

• 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 (internal training, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, 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 every day

Inclusion At Gsk:

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

#Li-Gsk

#Li-Hybrid

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 Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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/