Regulatory Specialist, Submission Delivery Excellence

Descrizione del lavoro:

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?
Basic 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.

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Work Arrangement
This role is hybrid with regular days in the office in Poland. The exact pattern will be agreed with your manager based on team and business needs.

How to apply
We encourage applicants from all backgrounds. We support inclusion and can provide adjustments during recruitment. If you are interested, please apply now to join Submission Delivery Excellence and help move important regulatory work forward.The annual base salary in Poland for new hires in this position ranges from PLN 89,250 to PLN 148,750 gross, taking into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer's discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.

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.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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.

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