Submission Lead, Submission Delivery Excellence, Lifecycle Management

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 Position Summary Are you ready to make a meaningful impact in a dynamic regulatory role As a Submission Lead in Submission Delivery Excellence Lifecycle Management you will play a key role in ensuring the timely and high-quality delivery of regulatory submissions You ll collaborate with cross-functional teams to support the lifecycle management of pharmaceutical products helping us get ahead of disease together We value candidates who are detail-oriented proactive and skilled at building relationships across teams This role offers opportunities for growth learning and contributing to a mission that improves lives worldwide Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career These responsibilities include some of the following Coordinate and deliver regulatory submissions ensuring compliance with global and local requirements Collaborate with cross-functional teams to compile and review submission packages including Chemistry Manufacturing and Controls CMC documentation Monitor regulatory changes and provide guidance to internal teams on evolving requirements Support audits and inspections ensuring adherence to regulatory and company standards Identify opportunities for process improvements and contribute to optimizing regulatory workflows Build and maintain strong relationships with internal and external stakeholders to ensure smooth regulatory processes Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals Bachelor s degree in pharmacy chemistry biotechnology or a related field Strong understanding of regulatory submission requirements and lifecycle management processes Excellent written and verbal communication skills in English Ability to manage multiple tasks and meet deadlines in a fast-paced environment Attention to detail and commitment to delivering high-quality work Preferred Qualification If you have the following characteristics it would be a plus Master s degree in regulatory affairs pharmacy or a related field Experience working in a matrixed international environment Familiarity with regulatory systems such as Veeva Vault or similar platforms Knowledge of global regulatory requirements including EU and US markets Strong interpersonal skills and ability to collaborate effectively across teams Demonstrated ability to engage and influence senior stakeholders 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 IN recruitment-adjustments gsk com 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 askus gsk com so that we can confirm to you if the job is genuine