Reg Submission Lead III, SDE - Pipeline

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

• →Accountable to Project Lead or GRL/ Regional Rep/ EU Agent / C&EP TG /LOC or equivalent with input from Functional teams (CMC/Clinical/nonclinical) for delivery of assigned submissions to agreed timeframes and appropriate content independently and confidently for EU, US and Rest of the World (ROW) market.
• →Responsible for coordinating the market expansion activities associated submissions for new registrations and line extensions including the initial NDA/MAAs, type 2 variations/supplements, pediatric submissions and responses to HAQs.
• →Works with staff from other functions and should be capable of working to senior levels in process development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues.
• →Possess in-depth knowledge of GSK processes, ways of working and provide training, consultation and solutions within the team/ department as well as externally outside the department.
• →Independently and confidently executes agreed dossier strategy related to assigned deliverables with minimal input from manager; escalate any issues with business impact and offers potential solution.
• →Ensure alignment and clear understanding of Regulatory Requirement/Legislation/ Guideline for EU, US and ROW markets, including Market Specific Requirements.
• →Proficiently use intelligence resources to determine MSR data package requirements and ensure they are fit for purpose.
• →Simultaneously manage multiple project assignments of varying complexity.
• →May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
• →May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
• →Serve as a reviewer for peers and identifies improvement opportunities for Regulatory processes, policies and systems.
• →May be required to lead or participate in process improvement initiatives

• Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
• Chemistry, pharmacy or other related science or technical bachelor’s degree.
• Masters degree or higher in biological or healthcare science
• Regulatory, Pharmaceutics, or other related science or regulatory affairs.  Project Management, Communication

• Proven Pharmaceutical experience commensurate with requirements of the position.
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products.
• Demonstrated proficiency with RIM systems to efficiently meet submission deliverable objectives while ensuring compliance.
• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
• Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience.
• Ability to build effective working relationships and work in a matrix environment effectively.
• Ability to think flexibly to meet constantly shifting priorities and timelines.
• Demonstrated ability to proactively manage workload, timelines and identify priorities.  Build relationships with relevant internal functions.
• Proven ability to work on multiple projects simultaneously.

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.

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 IN.recruitment-adjustments@gsk.com to discuss your needs.

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.

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 askus@gsk.com, so that we can confirm to you if the job is genuine.