Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D


Position Summary

This is the content - Regulatory Project Manager, New Registration CMC, CMC Excellence

Within the CMC RA group, the New Registration CMC team bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity, product expansion dossiers and CTA submissions. The New Registration CMC team provide regulatory support across for development and registration of new pharmaceutical, biopharm and vaccines products.

 

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

• Independently assesses, manages, and/or drives the CMC  submission  deliverables, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for clinical trials, marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the evolving regulatory requirements

• Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in-licensing and divestment projects, and provide guidance to R&D teams, Quality Control, GSC, QA and LOC

• Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus

• Ensures adequate contribution during interactions with Worldwide Regulatory Authorities.  Authors responses to Regulatory Agency questions

• Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions.  May engage and lead CMC Subject Matter Expert activities

• Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches

• Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems

• Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact

• Communicates, through the appropriate teams, complex regulatory issues across GSK and with external agencies and third parties as necessary

• Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, serves as dossier approver, identifies improvement opportunities, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines
  
  What we offer:

• Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.

• Established job in an international, well-known pharmaceutical company.

• Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets.

• Opportunity to work within GSK standards and documentation applied globally.

• Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).

• Supportive & friendly working environment

How to apply
If this role resonates with you, please apply and tell us how your experience matches the role. Share what motivates you to join GSK and how you would contribute. We look forward to your application.

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.

Inclusion at GSK:

As an employer committed to 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.

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.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing [email protected], so that we can confirm to you if the job is genuine.